Category: Top Selling Standards

IEC 62304, Medical device software – Software life cycle processes, is a critical part of many medical device technology requirements

Software is often an integral part of medical device technology. Establishing the safety and effectiveness of a medical device containing software requires knowledge of what the software is intended to do and demonstration that the use of the software fulfills those intentions without causing any unacceptable risks.

IEC 62304 provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software. The standard provides requirements for each life cycle process. Each life cycle process is further divided into a set of activities, with most activities then further divided into a set of tasks.

As a basic foundation the standard assumes that medical device software is developed and maintained within a quality management system and a risk management system. The medical device risk management system is already covered by ISO 14971.  So IEC 62304 references the ISO 14971 throughout the standard.  However, some minor additional risk management requirements are needed for software, especially in the area of identification of contributing software factors related to hazards.  These are covered by IEC 62304.

Whether software is a contributing factor to a hazard is determined as an activity of the risk management process.  Hazards that could be indirectly caused by software (for example, by providing misleading information that could cause inappropriate treatment to be administered) need to be considered. The decision to use software to control risk is made during the risk control activity.  Then the software risk management process required in this standard has to be embedded in the device according to ISO 14971.

Because many incidents in the field related to service or maintenance of medical device systems include inappropriate software updates and upgrades, the software maintenance process is considered to be as important as the software development process.  So maintenance is covered by the standard as well.

These documents, and all IEC and ISO Standards, can be purchased from Document Center Inc. at our website, www.document-center.com.  Or order by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Your questions and comments are welcome.

Document Center recommends Standard MSA, Measurement Systems Analysis, for assessing the quality of a measurement system

MSA, “Measurement Analysis System,” is the widely referenced standard for measurement system quality.  Generated by the automotive industry, the standard presents guidelines for assessing the quality of a measurement system.  Currently it’s the 4th Edition, released in June of 2010, with an errata from the same month.

Its primary focus is measurement systems where the readings can be replicated on each part.  The standard helps the user analyze the collection of equipment, operations, procedures, software and personnel that affects the assignment of a number to a measurement characteristic.

If you need to plan and prepare a Measurement System Analysis (MSA) program and understand process variation and its impact, this standard is for you.  It will provide insight into organizational applications, categories of measurement system variation, and gage repeatability and reproducibility.

MSA has direct application to ISO/TS 16949:2002, “Quality management systems – Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations,” as well.  So if you’re certifying to the ISO document, the MSA can provide practical information for meeting your requirements.

The MSA and ISO standards can be purchased from Document Center Inc. at our website, www.document-center.com.  Or call us (650-591-7600), fax us (650-591-7617) or email us (info@document-center.com) your request.  We’re here to help you with your standards needs.

BS EN 60601-1, Medical electrical equipment, General requirements for basic safety and essential performance, one of the essential Medical Device Standards

BS EN 60601-1:2006 is one of the essential standards to meet the requirements of the Medical Device Directive for sales of Medical Devices in the European Union.  Entitled “Medical electrical equipment. General requirements for basic safety and essential performance,” the standard is identical in content to the IEC 60601-1 Edition 3.0 from 2005.

BS EN 60601-1 is for intended for use by manufacturers, regulation bodies, independent certification bodies and professional users and beneficiaries of medical electrical equipment.

The standard applies to medical electrical equipment intended to be used in the diagnosis, treatment, or monitoring of a patient.  It focuses on the basic safety and essential performance of medical electrical equipment and medical electrical systems.

The standard is one of a group of standards in the 60601 series.  For a complete listing of the IEC 60601 series documents, here is our Document Center page with the complete listing – http://www.document-center.com/iec_60601.cfm.

And here is a link to our page on all the documents that are part of the harmonized standards list for the Medical Device Directive.

You’ll find both pages useful in identifying the documents you need in order to meet Medical Device regulations globally.  The standards are all available from Document Center Inc. on our website, www.document-center.com.  Or call us (650-591-7600), fax us (650-591-7617) or send us an email (info@document-center.com).  Your questions and comments are always welcome.

MIL-STD-883 H – The DoD’s top standard for Microcircuits — Plus a list of other relevant standards

MIL-STD-883 Revision H, entitled “Test Method Standard – Microcircuits,” is Document Center’s all-time best selling military standard.  It provides approximately 700 pages of tests for microelectronic devices suitable for use within Military and Aerospace electronic systems.  It includes basic environmental tests to determine resistance to deleterious effects of natural elements and conditions surrounding military and space operations; mechanical and electrical tests; and workmanship and training procedures.

Revision H was released on 2/26/2010 and compliance with the standard was required by 9/30/2010.  Usage of the standard is mandated as part of a contract with the U.S. government.

The document is intended to be used in conjunction with several other major military documents:
MIL-PRF-19500 – Semiconductor Devices, General Specification For.
MIL-PRF-38534 – Hybrid Microcircuits, General Specification For.
MIL-PRF-38535 – Integrated Circuits (Microcircuits) Manufacturing, General Specification For.
MIL-STD-1835 – Electronic Component Case Outlines.
MIL-HDBK-217 – Reliability Prediction of Electronic Equipment.
MIL-HDBK-505 – Definitions of Item Levels, Item Exchangeability, Models, and Related Terms.

There are also references to a number of industry standards that are basic to any standard library for electronic devices:

ISO 14644-1 – Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness.
ISO 14644-2 – Cleanrooms and Associated Controlled Environments – Part 2: Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1.
IPC-T-50 – Terms and Definitions for Interconnecting and Packaging Electronic Circuits.
ANSI/NCSL Z540.3 – Requirements for the Calibration of Measuring and Test Equipment, General Requirements
ANSI/J-STD-004 – Requirements for Soldering Fluxes
ANSI/J-STD-005 Requirements for Soldering Pastes
ANSI/J-STD-006 – Requirements for Electronic Grade Solder Alloys and Fluxed and Non-fluxed Solid Solders for Electronic Soldering Applications
IPC/EIA/JEDEC J-STD-002 Solderability Tests for Component Leads, Terminations, Lugs, Terminals and Wires.
EIA/JESD 22-B116 Wire Bond Shear Test
EIA/JESD 78 IC Latch-up Test.
EIA-557 Statistical Process Control Systems.
ASTM E263 – Standard Test Method for Measuring Fast-Neutron Reaction Rates by Radioactivation of Iron.
ASTM E264 – Standard Test Method for Measuring Fast-Neutron Reaction Rates by Radioactivation of Nickel.
ASTM E265 – Standard Test Method for Measuring Reaction Rates and Fast-Neutron Fluences by Radioactivation of Sulfur-32.
ASTM E666 – Standard Practice for Calculating Absorbed Dose from Gamma or X-Radiation.
ASTM E668 – Standard Practice for Application of Thermoluminescence-Dosimetry (TLD) Systems for Determining Absorbed Dose on Radiation Hardness Testing of Electronic Devices.
ASTM E720 – Standard Guide for Selection and Use of Neutron Sensors for Determining Neutron Spectra Employed in Radiation-Hardness Testing of Electronics.
ASTM E721 Standard Method for Determining Neutron Energy Spectra with Neutron-Activation Foils for Radiation-Hardness Testing of Electronics.
ASTM E722 – Standard Practice for Characterizing Neutron Energy Fluence Spectra in Terms of an equivalent Monoenergetic Neutron Fluence for Radiation-Hardness Testing of Electronics.
ASTM E801 Standard Practice for Controlling Quality of Radiological Examination of Electronic Devices.
ASTM E831 Standard Test Method for Linear Thermal Expansion of Solid Materials by Thermomechanical Analysis
ASTM E1249 – Minimizing Dosimetry Errors in Radiation Hardness Testing of Silicon Electronic Devices.
ASTM E1250 – Standard Method for Application of Ionization Chambers to Assess the Low Energy Gamma Component of Cobalt 60 Irradiators Used in Radiation Hardness Testing of Silicon Electronic Devices.
ASTM E1275 – Standard Practice for Use of a Radiochromic Film Dosimetry System.
ASTM F458 – Standard Practice for Nondestructive Pull Testing of Wire Bonds.
ASTM F459 – Standard Test Methods for Measuring Pull Strength of Microelectronic Wire Bonds.
ASTM F526 – Standard Test Method for Measuring Dose for Use in Linear Accelerator Pulsed Radiation Effects Tests.
ASTM F1892 – Standard Guide for Ionizing Radiation (Total Dose) Effects Testing of Semiconductor Devices.
ASTM C177 – Standard Test Method for Steady-State Heat Flux Measurements and Thermal Transmission Properties by Means of the Guarded Hot-Plate Apparatus.
ASTM C518 – Standard Test Method for Steady-State Heat Flux Measurements and Thermal Transmission Properties by Means of the Heat Flow Meter Apparatus.
ASTM D150 – Standard Test Methods for A-C Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulating Materials.
ASTM D257 – Standard Test Methods for D-C Resistance or Conductance of Insulating Materials.
ASTM D1002 – Standard Test Method for Strength Properties of Adhesives in Shear by Tension Loading (Metal-to-Metal).
ASTM D3850 – Standard Test Method for Rapid Thermal Degradation of Solid Electrical Insulating Materials By Thermogravimetric Method (TGA).

The MIL-STD-883, both the current Revision H and previous editions, as well as the other standards noted above, are all available from Document Center Inc.  Use our website, www.document-center.com, or phone (650-591-7600), fax (650-591-7617) or email us (info@document-center.com).  Any questions or comments you may have are welcome.

ISO/TS 16949 – Quality in the Automotive Industry

When ISO 9001, “Quality management systems — Requirements” was first released in 1987, it provided a platform on which to build a verifiable quality program in any business.  But over time, specific industries wanted to tailor the requirements to suit their particular needs.  Thus in 1999, ISO/TS 16949, “Quality management systems — Particular requirements for the application of ISO 9001 for automotive production and relevant service part organizations,” was issued.

The TS in the document number stands for Technical Specification.  This is a normative specification representing a level of technical consensus within an ISO committee.  It requires a consensus vote accepted by 66% of the committee members, rather than the 75% needed to create an ISO standard.

The current 2009 edition of the document includes the text of the ISO 9001:2008, with the paragraphs of the standard in boxed sections.  When needed, there is additional text providing additional commentary and requirements.  The convention in the document is that the word “shall” indicates a requirement.  The word “should” indicates a recommendation. Paragraphs marked “NOTE” are for guidance in understanding or clarifying the associated requirement.

ISO/TS 16949:2009 also includes an Appendix A, which covers Control Plans.  This includes both Phases of the control plan and Elements of the control plan.

The document has the support, and is copyrighted by, not only ISO but also ANFIA, FIEV, SMMT, VDA, and the companies Chrysler, Ford Motor Company, General Motors Corp., PSA Peugeot Citroen, and Renault.  It was written with the assistance of the International Automotive Task Force.

For automotive manufacturers and their supply chain, the ISO/TS 16949 remains a critical document for compliance with quality requirements in this industry.  The document, and all ISO standards, can be purchased from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Your questions and comments are welcome.

Use of BS EN 10204 for compliance with the Pressure Equipment Directive (97/23/EC)

BS EN 10204:2004, titled Metallic materials, Types of inspection documents, was published in support of the Directive for Pressure Equipment (97/23/EC).  This New Approach Directive allows for self-certification of compliance with European Regulations.  By following the EN standard when doing business in Europe, one can be assured of meeting the requirements of the Directive.  But what exactly is required?

This EN Standard specifies the different types of inspection documents supplied to the purchaser, in accordance with the requirements of the order, for the delivery of all metallic products, e.g. plates, sheets, bars, forgings, castings, whatever their method of production.  It may also apply to non-metallic products.

But the document itself does not contain any inspection directions. Indeed, it must be used in conjunction with the product specifications which specify the technical delivery conditions of the order itself.

So what exactly does it specify?

The document first of all defines a series of document type designations, like Type 2.1, Declaration of compliance with the order, and 2.2, Test report.  For each document type, there is a brief description of the content and the validating entity.

So for Type 2.1, Declaration of compliance with the order, the description is “Statement of compliance with the order” and the validating entity is the manufacturer.  For Type 2.2, Test report, the description is “Statement of compliance with the order, with indication of results of nonspecific inspection.”  The validating entity is again the manufacturer.

Terminology is defined in the beginning of the standard.  And a chart is provided to specifically show the use of EN 10204 to support the 97/23/EC Directive.  Reference is additionally made to EN 10168, Steel products – Inspection documents – List of information and description.

So, the BS EN 10204 does not describe specific requirements for any given order.  The expectation is that the order itself will define the product specifications required.  The document does however, define a series of document types issued by the manufacturer in which he declares that the products supplied are in compliance with the requirements of the order and in which he may supply test results if required.

The BS EN 10204 and all BS EN standards are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone at 650-591-7600, fax at 650-591-7617, or by email at info@document-center.com.  Your questions and comments are welcome.

SAE’s AMS Index – A useful tool for Aerospace Material Specifications

SAE International publishes the AMS Index every January and July and we at Document Center Inc. regularly sell it.  Why would people continue to purchase a paper index in today’s online world?  Because you can use it to locate standards based on specified conditions like material, form, quality and so on.  And not only are the AMS documents identified, but similar documents from other organizations, UNS numbers and Alloy information are included as well.

Let’s take a common AMS specification as an example:  AMS 5518, on corrosion resistant steel.  The first section of the index is in numerical order, so the document can be found in the numerical section, further classified by it’s position under Wrought Corrosion and Heat Resistant Steels and Alloys.

We see the revision level is L, the complete title is “Steel, Corrosion Resistant, Sheet and Strip 18Cr – 8Ni Cold Rolled, 150 Ksi (1034 MPa) Tensile Strength,” the UNS number is S30100, the alloy is 30301, and a similar specification is ASTM A480/A480M.

We could have also found the same document in the subject index under the alloy number, or in the similar specifications index under the ASTM A480/A480M number.  The subject index makes it fairly simple to find the references by the UNS number as well.

For folks who are using various metals and other materials for the aerospace industry, this index can prove very helpful in identifying which AMS standards or other documents should be used.

The index and all SAE documents (like the AMS, AS, MAM, and J Standards) can all be purchased from Document Center Inc. under licensed agreement with SAE.  Order on our website, www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  And if you have any questions on these documents, please let us know.

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

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.

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

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!

ISO-14971 – A guide to the document and it’s many reprints

ISO-14971:2007,  Medical devices — Application of risk management to medical devices, is a critical component to any medical device manufacturers core standards collection. However, many users get confused by the many adoptions and reprints of this standard.

According to ISO, the document itself “specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.”

It is an integral part of the Medical Device Quality Management System outlined by ISO-13485, Medical devices — Quality management systems — Requirements for regulatory purposes.

But the fact that the document is essential to a Medical Devices Quality system has meant that the document has been adopted and reprinted the world over.  The existence of many documents with “ISO-14971” in the document number but with differing dates makes choosing the right document difficult for some.

The reason for the many adoptions is the very popularity of the document itself.  For example, the European union has a scheme in place (harmonized standards) so that the requirements of legislation translate into regulation based on EN standards.   These standards have been produced under a mandate from the European Commission and adopted by Member States under the “New Approach” Directive.  And the EU is partial to the use of ISO standards whenever possible.

When legislation requires risk management to be adopted by companies selling medical devices in Europe, the use of the ISO-14971 is promptly identified as the standard to use.  However, the administrative process requires the ISO document to be adopted by the EU as an EN standard and then made publicly available as adoptions by the various countries of the EU as they are being put into use.  The BS-EN-ISO-14971 is the official English language edition, DIN-EN-ISO-14971 is the official German language edition, and so on.

Unfortunately, administrative activities have caused the issuance of 2009 Editions of the EN adoptions, out of sync with the current 2007 Edition of the ISO source document.  Customers do not realize that the ISO itself is stable in both the EN-14971:2007 and EN-14971:2009 Editions.  Only the administrative EN information has changed.

Another factor in the widespread reissuing of this document is the fact that when a country participates in the development of an ISO standard, they receive the right to reprint the standard in a national translation.  So, because AAMI is the U.S. “tag” (participant) for this committee, we have an American release of this standard, ANSI/AAMI/ISO-14971 2007 Edition.  The document has administrative information particular to the U.S. in the opening pages, much like the EN adoption.   Then the ISO edition is reprinted verbatim, except where English spelling conventions have been translated into the U.S. format (like “colour” vs. “color”).

You will find similar adoptions in Canada, Russia, Japan, and so on.

Our only comment to our customers is that the higher up the food chain you go, the “fresher” your information will be.  That is, the source document, ISO-14971, changes first and is released first.  Then each organization that issues a reprint of the item must go through the administrative formalities of adopting the new information.

However, many times the national translations of the ISO documents can be less expensive than the source material.  So if cost is a concern, you may want to check out the AAMI/ISO edition of the 14971.

Of course, to purchase ISO-14971 or the other documents mentioned above, they’re available from Document Center Inc. at www.document-center.com, info@document-center.com, and by phone at +650-591-7600 or fax at +650-591-7617.