Archive for October, 2010

Toy Safety Standards – European Standards

Friday, October 29th, 2010

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 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.

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MIL-PRF-19500 New Revision P on Semiconductor Devices Released 10/20/2010

Thursday, October 28th, 2010

MIL-PRF-19500 (formerly MIL-S-19500) titled Semiconductor Devices, General Specification for, has just been revised. This specification is one of the top Semiconductor specs for use by the Department of Defense.

The release of new 170 page Revision P requires compliance by April 20th, 2011.  Changes from the previous Revision N are extensive and are not noted in the margins, as is sometimes the case.

This specification covers the general requirements for semiconductor devices used in electronic equipment procured by the U.S. military.  The semiconductor devices covered by it are unique due to the fact that these devices must be able to operate satisfactorily in systems under demanding conditions such as: 20 g’s vibration, 100 g’s of shock, salt atmosphere, wide temperature range (e.g. -55°C to +150°C).  In addition, these requirements are verified under a qualification system.  Commercial components are not designed to withstand these environmental conditions.

MIL-PRF-19500P establishes the general performance requirements for semiconductor devices.  Detail requirements and characteristics are specified in the specification sheet.  Revisions to this specification and it’s corresponding specification sheets are structured to assure the interchangeability of devices of the same part type regardless of manufacturing date code or conformance inspection (CI) completion date.

Five quality levels for encapsulated devices are provided for in this specification, differentiated by the prefixes JAN, JANTX, JANTXV, JANJ, and JANS. Eight radiation hardness assurance (RHA) levels are provided for the JANTXV and JANS quality levels. These are designated by the letters M, D, P, L, R, F, G, and H following the quality level portion of the prefix. Two quality levels for unencapsulated devices are provided for in this specification, differentiated by the prefixes JANHC and JANKC.

The main body of this document specifies the performance requirements and requires the manufacturer to verify that their devices are capable of meeting those performance requirements.

Appendix A contains definitions of terms used throughout the specification.  Appendix B contains abbreviations and symbols.  Appendix C contains the Quality Management (QM) Program.  Appendix D contains the quality system.  Appendix E contains the standard verification system for qualified products.  Appendix F has been canceled.  Appendix G contains discrete semiconductor die/ship lot acceptance.  Appendix H contains critical interface and materials for semiconductor devices.

The document number was changed from MIL-S-19500 to MIL-PRF-19500 during the Mid-1990′s Mil Spec Reform to designate the performance specification status of the document.

Should you want to purchase a copy of this new specification, a previous edition, or any MIL Spec or Standard that’s publicly distributed, please go to our website, www.document-center.com, or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re always happy to be of assistance to you.

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International Toy Safety Standards

Wednesday, October 27th, 2010

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.

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Toy Safety Standards – U.S. Standards

Monday, October 25th, 2010

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.

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EN 1041 (aka BS EN 1041) on Information supplied by the manufacturer of medical devices critical for medical device manufacturers

Friday, October 22nd, 2010

The EN 1041 (normally sold as BS EN 1041, the official English language edition) is the European requirement for information supplied by the manufacturer of medical devices.   Frequently ordered by Document Center Inc. customers, the standard is part of the harmonized documents for the Medical Device Directive (93/42/EEC).

BS EN 1041 Information supplied by the manufacturer of medical devices

BS EN 1041 specifies the requirements for information to be supplied by a manufacturer, for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied.

BS EN 1041 is intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on the way that the requirements can be met. If a manufacturer follows BS EN 1041, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.

This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards.

When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.

Why has BS EN 1041 been revised?

BS EN 1041 has been revised to take account of changes in the Directives applicable to medical devices.

Since the time of approval of the first edition of this standard on 18 January 1998, the Medical Device Directive (MDD) (93/42/EEC) and Active Implantable Medical Device Directive (AIMDD) (90/385/EEC) have been amended. In addition, new methods of provision of information have become freely available and widely used.

The new edition is intended to make available guidance for manufacturers of medical devices that is appropriate regardless of the means used to disseminate that information and it is intended that it should, as far as possible, be suitable for future methods of provision of information.   In this standard, Directives 90/385/EEC and 93/42/EEC refer to the versions amended in 2007.

The requirements and guidance will provide manufacturers with appropriate means to ensure that their provision of information is relevant to all intended recipients and is in compliance with the Essential Requirements of the Directives. The requirements may also provide means by which compliance can be tested by regulatory and inspection agencies.

The possibility of providing information by alternative means is foreseen in Directives 93/42/EEC and 90/385/EEC and guidance on alternative labelling is provided.

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives 93/42/EEC and 90/385/EEC, as amended.

Practical guidance about the implementation of the essential requirements of the applicable Directives is included.

The relationship with EU Directives, (which are integral parts of this document) are also covered.

Contents of BS EN 1041 include:

  • Introduction
  • Scope
  • Normative references
  • Terms and definitions
  • Requirements
  • Units, symbols and colours
  • Language and country identifiers
  • Dates
  • Device nomenclature
  • Identifiers of nomenclature
  • Device common terms
  • Batch code; lot number; batch number; lot code
  • Requirements for provision of information
  • Specific requirements
  • Applicability
  • Accessibility
  • Legibility
  • Availability
  • Security
  • Changes to information provided
  • Documentation
  • Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as amended
  • Requirements and guidance for medical devices (Directive 93/42/EEC)
  • Requirements and guidance for active implantable medical devices (Directive 90/385/EEC)
  • Guidance on alternative labelling for instructions for use (IFU)
  • Guidance on alternative labelling for medical devices (Directive 93/42/EEC)
  • Guidance on alternative labelling for active implantable medical devices (Directive 90/385/EEC)
  • Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC
  • Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EC
  • Bibliography

BS EN 1041:2008 replaces BS EN 1041:1998 which remains current.  Both editions of the standard 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).  Should you have any questions about the document or about standards and regulations, please contact us.

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EN 980, Symbols for use in the labelling of medical devices, available in CD Rom format

Thursday, October 21st, 2010

The EN 980 (BS-EN-980 – Official English language edition) is the go-to document for Symbols for use in the labeling of medical devices for use in Europe.  However, the user of this important standard often wants to integrate the symbols themselves into the various labels and other information affiliated with the sale and use of these products.

This is where the CD Rom edition sold by Document Center Inc. comes in handy.  All the symbols in the EN-980 are readily available to use in manufacturer-supplied information.

The EN 980 European Standard was prepared to provide a single methodology for the presentation of information required by all of the European Directives on medical devices.

It highlights the legislative preference within the European Union for the use of symbols in medical device labelling, thereby reducing the need for multiple translations of words into national languages.  In addition, it was intended to simplify labelling wherever possible and to prevent separate development of different symbols to convey the same information.

View this page full sizeThe meaning of some of these symbols is self-evident. Some are already in widespread use and familiar to healthcare professionals. The meaning of others will become clear with use or when viewed in the context of the device itself. Symbols used with medical devices for use by other than healthcare professionals can require additional explanations.

In this respect, attention is drawn to the fact that risk management, e.g. the use of EN ISO 14971, is an integral element in medical device design and manufacturing. The use of appropriate symbols can, therefore, be an important element in risk reduction, which is a key part of risk management and is also specifically referred to in the relevant medical device directives. Symbols should only be used without explanation when risk assessment by the manufacturer indicates that it is appropriate.

The symbols in Clause 5 of this European Standard have been in general use for some time and users have some degree of familiarity with them. Additional symbols are now being introduced in Clause 6 which may be new or unfamiliar to users. As a precaution, Clause 6 requires that the meaning of these new symbols be explained in the information supplied by the manufacturer. This is without prejudice to the harmonization of this European Standard and the symbols in it.

It is not always possible to develop symbols for all information presented with the device. Not all symbols are appropriate for all types of medical devices. The validity of information conveyed by a symbol can be adversely affected by subsequent events e.g. damage to a package can affect the sterility of a device.

BS EN 980 includes examples of how some of the symbols can be used. These are illustrative only and do not represent the only ways in which the requirements of this standard can be met.

BS EN 980 also provides information about the use of the general prohibition symbol.

All EN documents are available for sale in the official English language editions from Document Center Inc. at our website, www.document-center.com, and by phone (650-591-7600), fax (650-591-7617) and email (info@document-center.com).  And if you have any additional questions, please ask us!

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Medical Device Standards – The Top 10 Standards on Vascular Stents

Tuesday, October 12th, 2010

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.

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New UL 796 Released on Printed-Wiring Boards

Monday, October 11th, 2010

The new UL-796 10th Edition on Printed Wiring Boards has just been released as of 10/8/2010.  This is one of Document Center’s best selling UL standards.  It covers both rigid and flexible boards.

The new edition covers the following material:

Revision to and Addition of Terms in Glossary

Clarification of Requirements for Standard Atmospheric Test Conditions in Paragraph 4.2

Clarification of Requirements for Acceptability of Printed Wiring Boards in Paragraph 7.1

Clarification of Requirements Regarding Base Material Relative Thermal Index in Paragraph 9.1.3

Clarification of Requirements for Base Material Sample Thickness Tolerances in Table 9.2

Addition of Requirements for the Condition of “As-Received Samples” in Paragraph 9.1.7

Clarification of Requirements for Metal-Clad Base Material in Section 9.2

Clarification of Requirements for Conductors in Paragraphs 10.2.1 and 10.6.1

Modification of Thickness of Edge Conductor in Figure 10.1

Clarification of Requirements for Plated Contact Fingers in Section 10.9

Clarification of Requirements for Multi-site Processing in Paragraph 12.2.1

Clarification of Requirements in Paragraphs 14.1 and 14.2 and Addition of Table 14.1 and Figures 14.1, 14.2, and 14.3 to Illustrate Requirements for Plugged-Hole Materials

Clarification of Requirements for Dissimilar Dielectric Material Bond Strength in Paragraph 17.6.1

Clarification of Requirements for the Evaluation of Metal Base Printed Wiring Boards in Section 18

Clarification of Requirements for Maximum Internal Copper Test Program in Paragraph 21.6

Clarification of Requirements for Conductor Measurements in Paragraphs 22.1, 22.4, and 22.5

Clarification of Requirements for Microsection Analysis in Paragraph 23.3.3

Clarification of Requirements for Flammability Classification in Paragraph 25.1.2

Clarification of Requirements for Bond Strength Temperature in Paragraph 26.3.1

Clarification of Requirements for Thermal Cycling Scheduling in Table 30.1

Clarification of Requirements for HDI Printed Wiring Board Constructions in Section 31; Addition of Table 20.10

Clarification of Requirements for Silver Migration Test in Paragraphs 32.2.1 and 32.2.5

Clarification of Marking Requirements in Paragraphs 33.2, 33.3, 33.6, and 33.10

Copies may be purchased on our website at www.document-center.com, by phone at 650-591-7600, via fax at 650-591-7617 or by emailing us at info@document-center.com.

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All time best selling Standards on Sampling and Statistical Process Control

Friday, October 8th, 2010

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-414, both 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.

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