Document Center’s Top 20 Best Selling Standards of 2013

It’s time to reflect on 2013 and what’s more fun that a List of Best Sellers?  So without further ado, here’s Document Center’s Top 20 Best Selling Standards of 2013:

  1. BS EN ISO 14971, 2012 Edition, Medical devices. Application of risk management to medical devices
  2. ASTM A967, 2013 Edition, Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts
  3. ASQ Z1.4, 2003 Edition Reaffirmed in 2013, Sampling Procedures and Tables for Inspection by Attributes
  4. BS EN ISO 13485, 2012 Edition with Corrigendum 1, Medical devices. Quality management systems. Requirements for regulatory purposes
  5. BS EN 1041, 2008 Edition with Amendment A1, Information supplied by the manufacturer of medical devices
  6. ASTM E1417, 2013 Edition, Standard Practice for Liquid Penetrant Testing
  7. IEC 60601-1, Edition 3.1 with Corrigendum 1, Medical electrical equipment – Part 1: General requirements
  8. ISO 9001, 4th Edition Corrected Reprint, Quality Management Systems — Requirements
  9. MEDDEV 2.12/1, Revision 8, Guidelines on a Medical Devices Vigilance System
  10. ASTM A240, 2013c Edition, Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications
  11. ASTM E18, 2012 Edition, Standard Test Methods for Rockwell Hardness of Metallic Materials
  12. ANSI Z540.3, 2006 Edition Reaffirmed in 2013, Requirements for the Calibration of Measuring and Test Equipment
  13. ASTM A380, 2013 Edition, Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems
  14. ASTM F1929, 2012 Edition, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
  15. ASTM B633, 2013 Edition, Standard Specification for Electrodeposited Coatings of Zinc on Iron and Steel
  16. ASTM F1140, 2013 Edition, Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
  17. IPC/EIA J-STD-002, Revision D, Solderability Tests for Component Leads, Terminations, Lugs, Terminals and Wires
  18. ISO 11137-2, 3rd Edition, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
  19. ASTM A276, 2013a Edition, Standard Specification for Stainless Steel Bars and Shapes
  20. ASTM D4332, 2013 Edition, Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing

If you need any of the above standards, head off to the Document Center webstore at www.document-center.com.  If you need us to monitor your standards to avoid missing updates like many of those documents in our list, please contact our staff.  We can be reached by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

With our extensive experience in helping customers identify, purchase, use and maintain their standards collection, we have the expertise to help you keep your conformance information valid and complete.  Do make us your Standards Experts!

Food Safety Standards for a Happy Thanksgiving!

Anyone who becomes familiar with standards is soon impressed by the fact that they are part of an invisible infrastructure that makes our lives far safer and easier.  And what better time to look at a side of standardization that you may have not considered in your everyday life than Thanksgiving and food safety standards?  Of course, there are many specific standards relating to components of food and the biological composition and safety of specific foods.  And there are standards for testing such attributes as taste and texture.  But I thought you might enjoy learning about the ISO management standards that address the basic processes and procedures for safe food handling and processing.

The ISO committee charged with issuing and maintaining Food Management Standards is Technical Committee 34, Subcommittee 17 (TC 34/SC 17).  Their standards are grouped in the 22000 numbering series and we will take a look at each one separately:

  • ISO 22000, 1st Edition with a Technical Corrigendum, Food safety management systems — Requirements for any organization in the food chain
  • ISO/TS 22002-1, 1st Edition, Prerequisite programmes on food safety — Part 1: Food manufacturing
  • ISO/TS 22002-2, 1st Edition, Prerequisite programmes on food safety – Part 2: Catering
  • ISO/TS 22002-3, 1st Edition, Prerequisite programmes on food safety – Part 3: Farming
  • ISO/TS 22003, 2nd Edition, Food safety management systems — Requirements for bodies providing audit and certification of food safety management systems
  • ISO/TS 22004, 1st Edition, Food safety management systems — Guidance on the application of ISO 22000:2005
  • ISO/TS 22005, 1st Edition, Traceability in the feed and food chain — General principles and basic requirements for system design and implementation

As you can see, the goal of these types of management standards is to provide a framework for consistent, well documented and executed processes, in this case to ensure the safe delivery of food to the ultimate consumer.

The schema is in line with the other management system standards.  The foundation document, the ISO 22000, provides the basic requirements for developing a food safety process that meets regulatory and customer needs.  It is set up so that an organization can be certified or registered to the standard.

The ISO/TS 22002 series provides specific details on various channels for food generation and handling.  These 3 technical specifications provide support for implementing specific clauses that are in the ISO 22000 document itself.  The documents cover such diverse aspects of food handling as the construction of buildings used for food handling, warehousing, biovigilance, cross-contamination, consideration of possible consumer vulnerabilities, and so on.

ISO/TS 22004 is a generic document, covering guidance on the various clauses of the ISO 22000.  Any user of the ISO 22000 will find this document helpful in clarifying the intention and meaning of the ISO 22000.

And lastly, the ISO/TS 22005 addresses the need for traceability in the food chain.  I’m sure that you’ve noticed when a food-borne health issue arises, health professionals are able to determine (sometimes with surprising accuracy) the source of the problem to implement corrective action.  In today’s world, with food arriving on our plates from locations worldwide, it is essential to be able to trace the source when health safety issues crop up.

Thanksgiving is getting a whole new meaning for me, as I discover that I have ancestors that were here in the United States in the 1600’s.  When I think of the difference in their way of life compared to ours, it is astounding.  We are able to provide a meal that has elements from places that I’m sure those first settlers had never heard of.

But with the food trade having a global reach, the need for an international system to ensure the safety of our food supply is essential.  When you sit down tomorrow to your big meal, I hope you will take a moment out to thank those members of the ISO TC34/SC 17 who have been hard at work providing the framework for the system that delivers a safe and healthful menu to you!

Of course, Document Center has all of these ISO standards and over 800,000 more documents available for you to purchase.  You can buy them on our web store at www.document-center.com.  Or you can contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We are able to provide you with additional support services, so if you use a management standards system in your business, please ask us how we can help you!  Remember, thousands of Document Center customers rely on us to keep their standards collections current.  Make us your Standards Experts!

Some of my favorite ASTM Standards

I’ve been selling standards for a long time!  Since 1985, I’ve owned and operated Document Center and have reviewed many ASTM standards over the years.  There are a few that have really caught my attention during that time and today I thought I’d mention some of those!

The first ASTM standard I really started to use a a training tool with my staff was the ASTM B633, “Standard Specification for Electrodeposited Coatings of Zinc on Iron and Steel.”  About the time we computerized Document Center back in 1987, there must have been a contract or drawing that had a typo.  Suddenly, customers were calling asking for the ASTM B663, “Standard Specification for Silver-Tungsten Carbide Electrical Contact Material.”  As soon as I would read them the title it was clear something was not right.

This was the first time I had been faced with an erroneous reference to a standard.  It took me a bit of searching, but I was correctly able to identify the mistake!  And it dawned on me that having experience with standards is a valuable asset.  For most standards users at that time, a typo in a document number was the end of the line.  So that’s why your customer service rep will always confirm the document number by reading you the title when you order at Document Center!

The next ASTM standard I get a kick out of is the ASTM E2082, “Standard Guide for Descriptive Analysis of Shampoo Performance.”  It provides a methodology to describe the look and feel of shampoo, as well as the performance of the formulation!  It amazes me sometimes the products that are affected by standards, and the degree to which products are reviewed in order to provide a pleasing and effective result.

And finally, I often get asked what I do, and of course when I say my company Document Center sells standards, I often get a blank look in response.  Now I have an easy way to explain to some people what I do and how it impacts their lives!

Way back when, my son and I were shopping for a birthday gift for one of his friends.  We decided to get him a Lego set, and as we were looking at the various options, I noticed that the box had an ASTM number on the side.  Back at the shop, I looked the standard up:  ASTM F963, “Standard Consumer Safety Specification for Toy Safety.”

Standards are part of our lives, every day in many ways.  If standards are a part of your business, use our web store, www.document-center.com, to purchase the documents you need.  If you have questions about standards or want to know more about a particular standard, contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re Your Standards Experts and we’re here to help you.

Food safety management standards from ISO

With all the recent interest in food safety for cross-border food supply chains, a review of the Food Safety Management Standards developed by ISO, the International Organization for Standards, seems appropriate.

The ISO 22000 series has been developed expressly for the purpose of helping organizations set up a good safety management system viable for international trade.

The ISO 22000 international standard is derived from  ISO-9001. It specifies the requirements for a food safety management system that involves interactive communication, system management, prerequisite programs, and HACCP (Hazard Analysis Critical Control Point) principles.

The documents in the series are:

ISO-22000:2005, Food safety management systems — Requirements for any organization in the food chain

ISO/TS-22004:2005, Food safety management systems — Guidance on the application of ISO 22000:2005

ISO/TS-22003:2007, Food safety management systems — Requirements for bodies providing audit and certification of food safety management systems

ISO-22006:2009, Quality management systems — Guidelines for the application of ISO 9001:2008 to crop production

ISO/TS-22002-1:2009, Prerequisite programmes on food safety — Part 1: Food manufacturing

Here is the abstract for the ISO-22000:

ISO 22000:2005 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of ISO 22000:2005 can be accomplished through the use of internal and/or external resources.

ISO 22000:2005 specifies requirements to enable an organization

— to plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer,

— to demonstrate compliance with applicable statutory and regulatory food safety requirements,

— to evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction,

— to effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain,

— to ensure that the organization conforms to its stated food safety policy,

— to demonstrate such conformity to relevant interested parties, and

— to seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to ISO 22000:2005.

The ISO-22004 is a generic guidance document for the ISO-22000.

For the ISO-22003, the abstract is as follows:

ISO/TS 22003:2007 defines the rules applicable for the audit and certification of a food safety management system (FSMS) complying with the requirements given in ISO 22000:2005 (or other sets of specified FSMS requirements), and provides the necessary information and confidence to customers about the way certification of their suppliers has been granted.

FSMS certification does not attest to the safety or fitness of the products of an organization within the food chain. However, ISO 22000:2005 requires an organization to meet all applicable food-safety-related statutory and regulatory requirements through its management system.

And for the ISO-22006, the abstract states:

ISO 22006:2009 gives guidelines to assist crop producers in the adoption of ISO 9001:2008 for crop production processes. The term “crop” includes seasonal crops (such as grains, pulses, oilseeds, spices, fruit and vegetables), row-planted crops that are cultivated, perennial crops that are managed over a period of time, and wild crops that are not formally planted or managed. Horticultural crops provide an even broader range of types from annual and perennial fruits, vegetables, and ornamental flowering plants to perennial shrubs and trees, and root crops. These diverse crops require a broad range of planting, cultivating, pest control, and harvesting methods and practices. Decisions regarding planting, growing, and harvesting activities can be similar, although specific steps can be quite different when considering the range of crops.

ISO 22006:2009 gives guidelines on the use and application of ISO 9001:2008 to the establishment and management of a quality management system (QMS) by an organization involved in crop production.

ISO 22006:2009 is not intended to change, add or reduce the requirements of ISO 9001:2008, nor is it intended for certification.

Further down the supply chain, in manufacturing processes, the language of ISO 9001:2008, ISO 15161 or ISO 22000 is considered more appropriate. The need for an ISO 9001:2008-based system containing agricultural terminology became apparent due to difficulties in the interpretation of the language of ISO 9001:2008 for crop production applications.

Lastly, for the ISO-22002-1, more information follows:

ISO/TS 22002-1:2009 specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRP) to assist in controlling food safety hazards.

ISO/TS 22002-1:2009 is applicable to all organizations, regardless of size or complexity, which are involved in the manufacturing step of the food chain and wish to implement PRP in such a way as to address the requirements specified in ISO 22000:2005, Clause 7.

ISO/TS 22002-1:2009 is neither designed nor intended for use in other parts of the food supply chain.

Food manufacturing operations are diverse in nature and not all of the requirements specified in ISO/TS 22002-1:2009 apply to an individual establishment or process.

Where exclusions are made or alternative measures implemented, these need to be justified and documented by a hazard analysis, as described in ISO 22000:2005, 7.4. Any exclusions or alternative measures adopted should not affect the ability of the organization to comply with these requirements. Examples of such exclusions include the additional aspects relevant to manufacturing operations listed under 1), 2), 3), 4), and 5) below.

ISO/TS 22002-1:2009 specifies detailed requirements to be specifically considered in relation to ISO 22000:2005, 7.2.3: a) construction and layout of buildings and associated utilities; b) layout of premises, including workspace and employee facilities; c) supplies of air, water, energy, and other utilities; d) supporting services, including waste and sewage disposal; e) suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance; f) management of purchased materials; g) measures for the prevention of cross-contamination; h) cleaning and sanitizing; i) pest control; j) personnel hygiene.

In addition, ISO/TS 22002-1:2009 adds other aspects which are considered relevant to manufacturing operations: 1) rework; 2) product recall procedures; 3) warehousing; 4) product information and consumer awareness; 5) food defence, biovigilance, and bioterrorism.

For additional information on these standards, to purchase them, or to talk with a standards expert on any other standards question, please contact us at info@document-center.com, by phone (650-591-7600) or fax (650-591-7617).  You can also use our website at www.document-center.com to search for any standards you’re interested in.

Toy Safety Standards – European Standards

The strong connection between European Union legislation and the corresponding “harmonized” standards has resulted in several important toy safety standards required for the sale of toys in Europe.  Released as EN standards, they can only be purchased as reprints available from each country in Europe as they are adopted.  Here’s the list of European Toy Safety Standards available in the official English language editions (BS-EN) from Document Center Inc.

EN-71-1 (BS-EN-71-1 – currently BS EN 71-1:2005+A9:2009),  Safety of toys. Mechanical and physical properties

BS EN 71-1 specifies requirements and methods of tests for mechanical and physical properties of toys.  It applies to toys for children, toys being any product or material designed or clearly intended for use in play by children of less than 14 years. It refers to new toys taking into account the period of foreseeable and normal use, and that the toys are used as intended or in a foreseeable way, bearing in mind the normal behavior of children.

BS EN 71-1 is aimed at reducing the risks which are not evident to users. It does not cover inherent dangers (e.g. instability of scooters, sharp needles in a sewing kit etc.) that are obvious to children or the persons in charge of them. Assuming that the toys are used in the manner for which they are intended, they should not present any further risk to children for whom they are intended.

BS EN 71-1 includes specific requirements for toys intended for children under 36 months and for children who are too young to sit up unaided. It also specifies requirements for packaging, marking and labeling.

EN-71-2 (BS-EN-71-2 – currently BS EN 71-2:2006+A1:2007), Safety of toys. Flammability

BS EN 71-2 covers the flammable materials which are prohibited in all toys and the requirements concerning flammability of certain toys when exposed to fire.

The tests described in this standard are used for determining the flammability of toys under the test conditions specified, the results cannot be considered as providing overall proof of the possible fire hazards of toys or their material when subjected to other types of flame.

The standard also lists the toys which are considered to present the greatest hazard to children.

EN-71-3 (BS-EN-71-3 – currently BS EN 71-3:1995, BS 5665-3:1995), Safety of toys. Specification for migration of certain elements

This part of this European Standard specifies requirements and test methods for the migration of the elements antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium from toy materials and from parts of toys except materials not accessible.

Requirements are included for the migration from the following toy materials:

  • coatings of paints, varnishes, lacquers, printing inks, polymers and similar coatings
  • polymeric and similar materials, including laminates, whether textile reinforced or not, but excluding other textiles
  • paper and paper board
  • textiles, whether natural or synthetic
  • glass/ceramic/metallic materials
  • other materials whether mass colored or not (e.g. wood, fiber board, hard board, bone and leather)
  • materials intended to leave a trace (e.g. the graphite materials in pencils and liquid ink in pens)
  • pliable modeling materials, including modeling clays, and gels
  • paints, varnishes, lacquers, glazing powders and similar materials in solid or in liquid form appearing as such in the toy.

Toys and parts of toys which, due to their accessibility, function, mass, size or other characteristics, obviously exclude any hazard due to sucking, licking or swallowing, bearing in mind the normal and foreseeable behavior of children, are not covered by this standard.

Packaging materials are not included unless they are part of the toy or have intended play value.

EN-71-4 (BS-EN-71-4 – currently BS EN 71-4:2009), Safety of toys. Experimental sets for chemistry and related activities

This part of the European Standard EN 71 specifies requirements for the maximum amount of certain substances and preparations used in experimental sets for chemistry and related activities. These substances and preparations are chemicals classified as dangerous by the Directives on dangerous substances and dangerous preparations  (including substances which have been self-classified according to the requirements of these Directives), substances and preparations which in excessive amounts may harm the health of the children using them but which are not classified as dangerous by the above mentioned Directives and any other chemical substances and preparations delivered with the toy.

This standard applies to chemistry sets and supplementary sets. It also covers toys for experiments within the fields of mineralogy, biology, physics, microscopy and environmental science whenever they contain one or more chemical substances and/or preparations. It also specifies requirements for marking, contents list, instructions for use and for equipment intended for carrying out the experiments. Other chemical toys are specified in EN 71-5.

NOTE:  The terms substance and preparation as used in directives 67/548/EEC  and 1999/45/EC  are also used in the REACH Regulation Regulation (EC) No 1907/2006. This latter regulation requires also that account be taken of the emerging international standards in the regulation of chemicals such as the Globally Harmonized System (GHS) of classification and labeling of chemicals. The EU has now proposed a timetable for the introduction of GHS and it is expected that the above two mentioned directives will be repealed on 1 June 2015. In the GHS regulation the term ‘mixtures’ rather than ‘preparation’ is used. Preparations and mixtures should be considered synonymous; both are mixtures or solutions of substances that do not react with each other.

EN-71-5 (BS-EN-71-5 – currently BS EN 71-5:1993+A2:2009, BS 5665-5:1993), Safety of toys. Chemical toys (sets) other than experimental sets

This part of EN 71 specifies requirements and test methods for the substances and materials used in chemical toys (sets) other than experimental sets.
It specifies:

  • the maximum amounts of substances and preparations classified as dangerous by the definitions in Directives 67/548/EEC  and 88/379/EEC ;  and
  • the maximum amounts of substances and preparations which in excessive amounts may harm the health of children using them and which are not covered by the above mentioned Directives;  and
  • the maximum amounts for other substances or preparations delivered with the toy.

Additionally, requirements are specified for markings, warning, safety rules, contents list, instructions for use and first aid information.

This Part of EN 71 applies to:

  • plaster of Paris (gypsum) molding sets;
  • ceramic and vitreous enameling materials supplied in miniature workshop sets;
  • oven hardening plasticized PVC modeling clay sets;
  • plastic molding sets;
  • embedding sets;
  • photographic developing sets;
  • adhesives, paints, lacquers, varnishes, thinners and cleaning agents (solvents) supplied or recommended in model sets.

EN-71-6 (BS-EN-71-6 – currently BS EN 71-6:1995, BS 5665-6:1995), Safety of toys. Graphical symbols for age warning labelling

This European Standard, a part of the EN 71 series, specifies requirements for the use and design of a graphical symbol for age warning labeling on toys not suitable for children under 3 years of age.

This standard does not apply to toys which on account of their function, dimensions, characteristics, properties or other cogent grounds are manifestly unsuitable for children under 3 years of age.

The purpose of the symbol is to inform adults that the toy might be hazardous to a child under 3 years of age.

EN-71-7 (BS-EN-71-7 – currently BS EN 71-7:2002), Safety of toys. Finger paints. Requirements and test methods

This part of EN 71 specifies requirements for the substances and materials used in finger paints and applies to finger paints only.

Additional requirements are specified for markings, labeling and containers.

EN-71-8 (BS-EN-71-8 – currently BS EN 71-8:2003+A4:2009), Safety of toys. Swings, slides and similar activity toys for indoor and outdoor family domestic use

This part of EN 71 specifies requirements and test methods for activity toys for domestic family use often attached to or incorporating a crossbeam, and similar toys intended for children under 14 years of age to play on or in and to bear the mass of one or more children. This part of EN 71 also specifies requirements for:

– separately sold accessories for, and components of activity toys;

– separately sold swing elements that are ready for use on or in combination with activity toy;

– construction packages for activity toys including components used to build activity toys according to a scheduled building instruction.

The scope excludes equipment intended for use in schools, kindergartens, public playgrounds, restaurants, shopping centers and similar public places dealt with in EN 1176 part 1 to 6.

EN-71-9 (BS-EN-71-9 – currently BS EN 71-9:2005+A1:2007), Safety of toys. Organic chemical compounds. Requirements

This Part 9 of the document EN 71 for safety of toys specifies requirements for the migration or content of certain hazardous organic chemical compounds from/in certain toys and toy materials (see Table 1) by the following exposure routes:
– mouthing
– ingestion
– skin contact
– eye contact
– inhalation
when used as intended or in a foreseeable way, bearing in mind the normal behavior of children and the function and design of the toy.
This document does not contain requirements for chemical toys, experimental sets or finger-paints, which are addressed by other parts of EN 71.
Packaging materials used with toys are not within the scope of the document unless they form part of the toy or have intended play value.

EN-71-10 (BS-EN-71-10 – currently BS EN 71-10:2005), Safety of toys. Organic chemical compounds. Sample preparation and extraction

BS EN 71-10 is a safety standard that helps to ensure that toys sold in the European Community are safe for children. The standard lays down the procedures to be followed when sampling and extracting toys and toy materials prior to chemical analysis. BS EN 71-10 is intended to be used in conjunction with BS EN 71-9, which stipulates requirements for organic chemicals in toys, and BS EN 71-11, which specifies the methods of analysis to be used for the determination of these organic chemicals. The standard is aimed at toy manufacturers, toy importers, enforcement authorities and test houses.

EN-71-11 (BS-EN-71-11 – currently BS EN 71-11:2005), Safety of toys. Organic chemical compounds. Methods of analysis

BS EN 71-11 is a safety standard that helps to ensure that toys sold in the European Community are safe for children to play with. The standard specifies the methods of analysis to be used for the identification and determination of organic chemicals in toys and toy material extracts. Methods have been elaborated and validated for various types of chemicals, e.g. flame retardants, colorants and preservatives. BS EN 71-11 is intended to be used in conjunction with BS EN 71-9, which stipulates requirements for organic chemicals in toys, and BS EN 71-10, which lays down the procedures to be followed when sampling and extracting toys prior to chemical analysis. The standard is aimed at toy manufacturers, toy importers, enforcement authorities and test houses.

EN-62115 (BS-EN-62115 – currently BS EN 62115:2005), Electric toys. Safety

BS EN 62115 is the European Standard which deals with the safety of toys that have at least one function dependent on electricity.

Examples of toys also within the scope of this standard are:

– Constructional sets
– Experimental sets
– Functional toys (models that have a function similar to an appliance or installation used by adults)
– Video toys (toys consisting of a screen and activating means, such as a joystick or keyboard. Separate screens having a rated voltage exceeding 24 V are not considered to be a part of the toy).

Additional requirements for experimental sets are given in Annex A.

Toys using electricity for secondary functions are within the scope of BS EN 62115.

A doll’s house having an interior lamp is an example of such a toy.

Additional requirements for toys incorporating lasers and light-emitting diodes are given in Annex E.

In order to comply with this standard, electric toys also have to comply with EN 71, since it covers hazards other than those arising by the use of electricity.

Transformers for toys and battery chargers are not considered to be a toy, even if supplied with it.

If it is intended that a child also plays with the packaging, the latter is considered to be part of the toy.

BS EN 62115 does not apply to:

  • Toy steam engines;
  • Scale models for adult collectors;
  • Folk dolls and decorative dolls and other similar articles for adult collectors;
  • Sports equipment;
  • Aquatic equipment intended to be used in deep water;
  • Equipment intended to be used collectively in playgrounds;
  • Amusement machines (IEC 60335-2-82);
  • Professional toys installed in public places (shopping centers, stations, etc.);
  • Products containing heating elements intended for use under the supervision of an adult in a teaching context;
  • Portable child-appealing luminaires (IEC 60598-2-10);
  • Christmas decorations.

All these toy standards and more are available from Document Center Inc. at www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) and email (info@document-center.com).  And please feel free to comment or check in with us should you have any questions about these or any other standards.

International Toy Safety Standards

If we consider International Standards to be the “Big 3”, ISO, IEC, and ITU, we find that both ISO and IEC have standards relating to toys.  So to follow up on Monday’s blog on U.S. Toy Standards, today we’ll review the International Standards on the topic that we sell at Document Center Inc.

First, I’d like to bring the following joint Guide to your attention:

ISO/IEC-Guide 50, Safety aspects — Guidelines for child safety:

This Guide provides a framework for addressing potential sources of unintentional physical harm (hazards) to children from products, processes or services that they use or with which they may come into contact, even if they are not specifically intended for children. The framework aims at minimizing risk of injury to children.

It is primarily intended for those involved in the preparation and revision of standards. However, it has important information that can be useful to, amongst others, designers, architects, manufacturers, service providers, communicators and policy makers.

For children with special needs, additional requirements may be appropriate. This Guide does not claim to address those additional requirements in full. ISO/IEC Guide 71 addresses the needs of persons with disabilities.

A product may include goods, structures, buildings, installations or a combination of these.

No specific guidance is given in this Guide for the prevention or reduction of psychological or moral harm or of intentional injuries.

Now, the IEC standards on Toys:

IEC-62115, Electric toys – Safety.  By the way, there is a new Amendment 2 for this standard which should be available soon.

Deals with the safety of toys that have at least one function dependent on electricity.  Examples of toys within the scope of this standard are constructional sets; experimental sets; functional toys (having a function similar to an appliance or installation used by adults) and video toys (toys having a screen and means of activation, such as a joystick or keyboard. Separate screens having a rated voltage of more than 24 v are not considered to be part of the toy).  Toys using electricity for secondary functions are also within the scope of this standard (a dolls house having an interior lamp is an example of such a toy).

IEC-61558-2-7, Safety of power transformers, power supplies, reactors and similar products – Part 2-7: Particular requirements and tests for transformers and power supplies for toys:

This part of IEC 61558 deals with safety aspects of transformers for toys and power supplies incorporating transformers for toys such as electrical, thermal and mechanical safety. This second edition cancels and replaces the first edition published in 1997. It constitutes a technical revision. The main changes consist of updating this Part 2-7, in accordance with Part 1, edition 2, and adding power supplies to the scope. This Part 2-7 has the status of a group safety publication in accordance with IEC Guide 104.

And the ISO standards:

ISO-8124-1, Safety of toys — Part 1: Safety aspects related to mechanical and physical properties:

The requirements in ISO 8124-1:2009 apply to all toys, i.e. any product or material designed or clearly intended for use in play by children under 14 years of age. They are applicable to a toy as it is initially received by the consumer and, in addition, they apply after a toy is subjected to reasonably foreseeable conditions of normal use and abuse unless specifically noted otherwise.

The requirements of ISO 8124-1:2009 specify acceptable criteria for structural characteristics of toys, such as shape, size, contour, spacing, as well as acceptable criteria for properties peculiar to certain categories of toy.

ISO 8124-1:2009 specifies requirements and test methods for toys intended for use by children in various age groups from birth to 14 years. It also requires that appropriate warnings and/or instructions for use be given on certain toys or their packaging. Due to linguistic problems that may occur in different countries, the wording of these warnings and instructions is not specified but given as general information in Annex B. It should be noted that different legal requirements exist in many countries with regard to such marking.

ISO 8124-1:2009 does not purport to cover or include every conceivable potential hazard of a particular toy or toy category. Except for labelling requirements indicating the functional hazards and the age range for which the toy is intended, it has no requirements for those characteristics of toys that represent an inherent and recognized hazard that is integral to the function of the toy

ISO-8124-2, Safety of toys — Part 2: Flammability:

ISO 8124-2:2007 specifies the categories of flammable materials that are prohibited in all toys, and requirements concerning flammability of certain toys when they are subjected to a minor source of ignition.

The test methods described are used for the purposes of determining the flammability of toys under the particular test conditions specified. The test results thus obtained cannot be considered as providing an overall indication of the potential fire hazard of toys or materials when subjected to other sources of ignition.

ISO 8124-2:2007 includes general requirements relating to all toys and specific requirements and methods of test relating to the following toys, which are considered as being those presenting the greatest hazard:

  • toys to be worn on the head: beards, moustaches, wigs, etc., made from hair, pile or material with similar features; molded and fabric masks; hoods, head-dresses, etc.; flowing elements of toys to be worn on the head, but excluding paper novelty hats of the type usually supplied in party crackers;
  • toy disguise costumes and toys intended to be worn by a child in a play;
  • toys intended to be entered by a child;
  • soft-filled toys (animals and dolls, etc.) with a piled surface or textile surface.

ISO-8124-3, Safety of toys — Part 3: Migration of certain elements:

ISO 8124-3:2010 specifies maximum acceptable levels and methods of sampling and extraction prior to analysis for the migration of the elements antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium from toy materials and from parts of toys.

Maximum acceptable levels are specified for the migration of the elements listed above from the following toy materials:

  • coatings of paints, varnishes, lacquers, printing inks, polymers and similar coatings;
  • polymeric and similar materials, including laminates, whether textile-reinforced or not, but excluding other textiles and non-woven textiles;
  • paper and paperboard, up to a maximum mass per unit area of 400 g/m2;
  • natural, artificial or synthetic textiles;
  • glass/ceramic/metallic materials, excepting lead solder when used for electrical connections;
  • other materials, whether mass-coloured or not (e.g. wood, fibreboard, hardboard, bone and leather);
  • materials intended to leave a trace (e.g. the graphite materials in pencils and liquid ink in pens);
  • pliable modelling materials, including modelling clays and gels;
  • paints to be used as such in the toy, including finger paints, varnishes, lacquers, glazing powders and similar materials in solid or liquid form.

The requirements in ISO 8124-3:2010 apply to the following toys and toy components of toys and toy materials:

  • all intended food and oral contact toys, cosmetic toys and writing instruments categorized as toys, irrespective of any age grading or recommended age labelling;
  • all toys intended for or suitable for children up to 72 months of age;
  • accessible coatings, irrespective of any age grading or recommended age labelling;
  • accessible liquids, pastes, gels (e.g. liquid paints, modelling compounds) irrespective of any age grading or recommended age labelling.

ISO-8124-4, Safety of toys — Part 4: Swings, slides and similar activity toys for indoor and outdoor family domestic use:

ISO 8124‑4:2010 specifies requirements and test methods for activity toys for domestic family use intended for children under fourteen years to play on or in.

Products covered by ISO 8124‑4:2010 include swings, slides, seesaws, carousels, rocking toys, climbing frames, fully enclosed toddler swing seats and other products intended to bear the mass of one or more children.

ISO-8098, Cycles — Safety requirements for bicycles for young children:

This International Standard specifies safety and performance requirements and test methods for the design, assembly and testing of bicycles for young children of from about four to eight years of age and these bicycles’ sub-assemblies. It also provides guidelines for instructions on the use and care of the bicycles.

This International Standard is applicable to bicycles with a maximum saddle height of more than 435 mm and less than 635 mm propelled by a transmitted drive to the rear wheel.

It is not applicable to special bicycles intended for stunting (e.g. BMX bicycles).

These standards, and all standards from the organizations mentioned, are available from Document Center Inc. at www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Again, your comments and questions are welcome.

Toy Safety Standards – U.S. Standards

With the holiday season right around the corner, the Consumer Product Safety Commission is bringing the issue of safety of toys and toy imports back into the headlines.   CPSC Chairman Inez Tenenbaum’s current visit to China raises questions again regarding the impact of standards on our imports.

Standards have played an important role here in the U.S.  in keeping children’s products safe since the 1970’s.  We’ll be using the blogs this week to discuss the various standards and regulations we sell at Document Center Inc. that impact toy makers and anyone in the toy industry.

U.S. toy standards are released by ASTM, ANSI and UL.  Here’s a list of these documents:

ASTM-F963, Standard Consumer Safety Specification for Toy Safety:

1. Scope

1.1 This specification relates to possible hazards that may not be recognized readily by the public and that may be encountered in the normal use for which a toy is intended or after reasonably foreseeable abuse. It does not purport to cover every conceivable hazard of a particular toy. This specification does not cover product performance or quality, except as related to safety. Except for the labeling requirements pointing out the functional hazards and age range for which the toy is intended, this specification has no requirements for those aspects of a toy that present an inherent and recognized hazard as part of the function of the toy. Such an example is a sharp point necessary for the function of a needle. The needle is an inherent hazard that is well understood by the purchaser of a toy sewing kit, and this hazard is communicated to the user as part of the normal educational process.

1.2 On the other hand, while a riding toy has inherent hazards associated with its use (for example, falling off onto the sidewalk), the possible hazards associated with its construction (sharp edges, exposed mechanisms, etc.) will be minimized by the application of this specification.

1.3 This specification covers requirements and contains test methods for toys intended for use by children under 14 years of age. Different age limits for various requirements will be found in this specification. These limits reflect the nature of the hazards and expected mental or physical ability, or both, of a child to cope with the hazards.

UL-696, Electric Toys:

1 Scope

1.1 These requirements cover electrically-operated toys including miniatures of full-sized appliances that may not necessarily perform the expected function of the copied appliance and that are intended to be used on nominal 120-volt branch circuits. The package for the toy, including packaging material if intended to be used with the toy, is considered to be a part of the toy and is covered by these requirements. An electric product is considered a toy if it is designed, manufactured, or marketed as a plaything for children over the age of 3.

1.2 For a toy that mimics the form or function of an established general-use appliance, the established requirements applicable to the general-use appliance shall be considered in defining the particular requirements applicable to the toy. Among the considerations that may be applicable are normal and abnormal test conditions. The requirements of the standard covering the general-use appliance shall not reduce the level of requirements addressed by this standard, but shall supplement the content of this standard as appropriate.

1.3 These requirements do not cover toys for outdoor use, sewing machines, flatirons, toys that operate with water, toys that operate with a gas or liquid under pressure (such as a steam engine), toy transformers, or toys intended to operate from the secondary of a toy transformer at a potential of 30 volts rms (42.4 volts peak) or less.

ASTM F1148, Standard Consumer Safety Performance Specification for Home Playground Equipment:

1. Scope

1.1 This consumer safety specification provides safety requirements for various types of home playground equipment intended for use by children aged from over eighteen months through 10 years. It further provides such requirements for swings intended specifically for toddlers. Different age limits for various requirements are found in this specification. These limits reflect the nature of the hazards and the expected mental or physical ability, or both, of the child to cope with the hazards.

1.2 Home playground equipment is defined as any product in which the support structure remains stationary while the activity is taking place and is intended for a child to perform any of the following activities: climbing, swinging, sliding, rocking, spinning, crawling, or creeping, or combination thereof. Fitness equipment is specifically excluded unless attached to the play equipment. This specification is not intended to apply to juvenile care products such as, but not limited to, infant swings, playpens/enclosures, beds, or furniture (including outdoor furniture, such as picnic tables, cradle rockers, activity centers being used as walker substitutes, bouncers, jumpers, infant carriers, and products specifically designed for therapeutic use). This specification is not intended to apply to equipment to be used in places of public assembly such as schools, nurseries, day-care centers, and parks. Equipment intended to be in child-care centers in private homes is not exempt from the requirements of this specification. Such centers are defined as situations in which the child-care provider does not care for more than six children under the age of ten that are not residing in the household of the caregiver, and the total number of children under the age of ten does not exceed ten, including the caregiver’s own children. Electrically operated constant air inflatable devices are exempted from the requirements of this specification.

1.3 Methods of identifying products that comply with this consumer safety specification are given. The illustrations of home playground equipment shown in Figs. A1.1-A1.4 are for informational purposes only and are not intended to limit or endorse certain types of playground equipment or equipment features. These illustrations are not intended to limit the variety or various combinations of equipment that are covered by this consumer safety specification.

1.4 The purpose of this specification is to reduce the likelihood of life-threatening or debilitating injuries.

1.5 If toy accessories or toy chests are attached to home playground equipment, they are applicable to this consumer safety specification and to any other applicable safety standards.

ANSI Z315.1, American National Standard for Tricycles:

This standard covers the safety requirements for all tricycles intended for use by children 8 years and under.

ASTM F834, Standard Consumer Safety Specification for Toy Chests:

1. Scope

1.1 This consumer safety specification covers the performance requirements and test methods to ensure the safety of toy chests.

1.2 This consumer safety specification is intended to minimize the accidents and injuries to children resulting from normal use and reasonably foreseeable misuse or abuse of toy chests.

1.3 For the purposes of this consumer safety specification, these requirements apply to products known as toy chests or toy boxes that are designed and marketed as storage containers for toys. The products subject to the requirements are those with a volume of 1.1 ft3 (0.031 m3) or more.

1.4 No toy chest or toy box produced after the approval date of this consumer safety specification shall, either by label or other means, indicate compliance with this specification unless it conforms to all requirements contained herein.

ASTM F1313, Standard Specification for Volatile N-Nitrosamine Levels in Rubber Nipples on Pacifiers:

This specification applies to the nitrosamine content of rubber used in the manufacture of nipples for infant pacifiers. This specification is intended for use in reducing the normal exposure to nitrosamines. Methylene chloride extraction method shall be used to determine the nitrosamine levels.

All 6 of these standards and more are available at the Document Center Inc. website, www.document-center.com, and by phone (650-591-7600), fax (650-591-7617) and email (info@document-center.com).  Please contact us if there are any questions about toy and safety standards.

Medical Device Standards – The Top 10 Standards on Vascular Stents

Vascular stents are the tubes that are placed in blood vessels to improve the flow of blood, either by preventing or counteracting a localized flow constriction.  Standards for those stents have been in force since the beginning of the 21st century.  Here are our top ten standards on the subject:

ASTM-F2079, Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

ASTM-F2081, Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

ASTM-F2394, Standard Guide for Measuring  Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

ASTM-F2477, Standard Test Method for in vitro Pulsatile Durability Testing of Vascular Stents

ASTM-F2514, Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

ASTM-F2606, Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems

ISO-25539-2, Cardiovascular Implants – Endovascular Devices – Part 2: Vascular Stents

ANSI/AAMI/ISO-25539-2, Cardiovascular Implants – Endovascular Devices – Part 2: Vascular Stents

BS-EN-ISO-25539-2, Cardiovascular Implants – Endovascular Devices –  Vascular Stents

All of the above standards can be purchased from Document Center Inc.  Buy them at www.document-center.com, or phone 650-591-7600, fax 650-591-7617, or email info@document-center.com.

All time best selling Standards on Sampling and Statistical Process Control

It’s said if you can measure it, you can manage it, and Statistical Process Control is the tool to use!  So it’s no surprise that there are a wide range of standards on the subject.  Here’s our list of the top 10 Standards on Sampling and Statistical Process control.

ASQ-Z1.4, Sampling Procedures and Tables for Inspection by Attributes

ASQ-Z1.9, Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming

These 2 Standards replace MIL-STD-105 and MIL-STD-414both of which are now obsolete. Filled with pages of tables for use with a continuous supply, the documents are our current best-selling sampling standards.  The Z1.4 covers go/no go data, the Z1.9 covers measurement.

Zero Acceptance Number Sampling Plans is often used as an alternative to the MIL-STD-105/ASQ-Z1.4 Inspection systems.  It is based on C=0 concept developed by author Nicholas Squeglia back in 1961.  The 5th edition is the current revision of this item.

During the last few years, the ISO standards on this topic have seen greater usage as well.  Top sellers include the ISO-2859 series, the ISO-11462 series, the ISO-3534 series, and the ISO-5725 series.

ISO-2859-10, Sampling procedures for inspection by attributes – Part 10: Introduction to the ISO 2859 series of standards for sampling for inspection by attributes, is a good starting point for the ISO-2859 set.  It provides a general introduction to acceptance sampling by attributes and provides a brief summary of the attribute sampling schemes and plans used in Parts 1 through 5. The standard also provides guidance on the selection of the appropriate inspection system for use in a particular situation.

ISO-11462-1, Guidelines for implementation of statistical process control (SPC) – Part 1: Elements of SPC, and ISO-11462-2, Guidelines for implementation of statistical process control (SPC) – Part 2: Catalog of Tools and Techniques, are two additional useful standards.  They provide concepts, tools and techniques to help an organization in planning, implementation and evaluation of an effective statistical process control (SPC) system.

ISO-5725-1, Accuracy (trueness and precision) of measurement methods and results – Part 1: General principles and definitions, is an introduction to the ISO-5725 series.  It outlines the general principles to be understood when assessing accuracy of measurement methods and results.  It can also be used to establish practical estimations of the various measures by experiment.  The standard may be applied to a very wide range of materials, including liquids, powders and solid objects, manufactured or naturally occurring.

For Statistics – Vocabulary and symbols, the ISO-3534 series covers all the bases:

ISO-3534-1, Part 1: General statistical terms and terms used in probability

ISO-3534-2, Part 2: Applied statistics

ISO-3534-3, Part 3: Design of experiments

ASTM International (formerly the American Society for Testing and Materials) also has a number of standards on the topic of Sampling and Statistical Process Control.  We often sell the following:

ASTM-E122, Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process.  This standard is intended for use in determining the sample size required to estimate, with specified precision, a measure of quality of a lot or process. The practice applies when quality is expressed as either the lot average for a given property, or as the lot fraction not conforming to prescribed standards.

Should you have any questions about the above standards, or need more suggestions to get the information you need, please contact us at www.document-center.com, info@document-center.com, or phone us at 650-591-7600.  We’re always ready to help you out.

Top Quality Standards for the Aerospace Industry

Our Top Quality Standard for the Aerospace Industry is the AS-9100,  Quality Management Systems – Requirements for Aviation, Space and Defense Organizations.  It is the successor document to the first Aerospace Quality Standard, the now obsolete AS-9000.  The current Revision C dated in 2009 will replace the previous Revision B in July 2012.

SAE International states that the document “specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.”

The next Quality Standard is the AS-9110, Quality Management Systems – Requirements for Aviation Maintenance Organizations.  This is the standard for certification for Maintenance groups.  Built on the foundation of ISO-9001, the additional aviation maintenance industry requirements, definitions and notes are highlighted in the text of this standard.

And the final certification standard in the series is the AS-9120,  Quality Management Systems – Requirements for Aviation, Space and Defense Distributors.  Again, the document is based on the ISO-9000, with deviations in the text highlighted for use by distributors.

Next on our list is the AS-9101, Quality Management Systems Audit Requirements for Aviation, Space, and Defense Organizations.  This essential standard provides you with the requirements for the actual audit.  It is the guide by which a certification process will be judged.

We should also mention AS-9003 at this point,  Inspection and Test Quality System.  SAE International states, “This document contains the minimum requirements for supplier Inspection and Test Quality System. It is emphasized that the quality system requirements specified in this standard are complementary (not alternative) to the contractual and applicable law and regulatory requirements.”

Another standard in this series is the AS-9006,  Deliverable Aerospace Software Supplement for As9100a.  However, as the AS-9100 Revision A is now obsolete, this document is not useful for new projects.

And the last standard we need to reference in this list is AS-5553, Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition.  With the quality concerns that arise from the use of sub-standard component parts, this standard is essential to the manufacture of safe products.

At the time of this post, draft documents are under review for the AS-9110, AS-9003 and AS-5553 Standards.