IEC 60601-1 Archives - Document Center's Standards Forum

IEC TR 60601-4-3 Released – Recommendations for IEC 60601-1

IEC TR 60601-4-3, “Medical electrical equipment – Part 4-3: Guidance and interpretation – Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements,” has just been released. This new Technical Report provides the user with insight into areas in the existing edition of IEC 60601-1 that expert users feel need to be updated. For manufacturers of medical electrical equipment, the testing labs they use, and the developers of the next edition of the IEC 60601-1 standard, this represents an early review of questions on interpretation that have come up and the working group’s recommendations for each.

This is a lengthy document, numbering 100 pages, with tabular information for 93 recommendations. Each item is presented in the same format, a grid with the following fields on the left and the committee’s data on the right:

Recommendation number
Requirement, clause/subclause numbering from the IEC 60601-1
Source/problem as submitted to the working group (WG 14)
Discussion/comment from the submitter of the initial question
Submitter proposed recommendation when available
The working group final recommendation

Annex A provides you with a table that is sorted by the IEC 60601-1 clauses in numerical order, so that you can easily find any recommendations for a specific clause in the original document. A 5-page bibliography completes the report. It looks like only Clauses 1, 6, and 12 have managed to squeak by without suggested changes!

Why would you care about these recommendations? One critical issue for medical electrical equipment manufacturers is meeting new requirements within the “grace period” for transitioning from one edition of a standard to the next. Gap analysis can be extensive and changes to products, assembly lines, and required tests take time. A document like the IEC TR 60601-4-3 provides you with a preliminary review of the areas where changes are possible and the likely outcomes. Further, if there are recommendations that you feel are not “best practices,” you now have time to contact the TAG (technical advisory group) in your country that participates in the development of the IEC 60601-1 with your concerns. This is a proactive stance that has come to be known as strategic standardization.

Meantime, you’ll want to get a copy of IEC TR 60601-4-3 from an authorized distributor and Document Center Inc. is your answer! Head to our webstore at www.document-center.com and order online in both paper and pdf format. Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) to learn more about our Standards Online multi-user subscription service. We have the tools for you to use to manage your standards in a cost-effective and compliant way. Make us your Standards Experts!

IEC 60601-1 Interpretation Sheet issued to clarify Subclause 13.1.2

IEC 60601-1 Edition 3.1, “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance,” has just had Interpretation Sheet 3 released. The Interpretation Sheet is available from Document Center Inc. in both paper and pdf format.

The IEC 60601-1 is the General Overview document for the IEC 60601 Series. It has been adopted by countries the world over as the benchmark for the import of medical devices. The standard is usually republished as a national or regional edition to account for the variances in country specific requirements.

The IEC Interpretation Sheets are issued when a section of a standard needs to be clarified by the committee. The impetus for the release is usually one or more requests by users of the standard. There is a strict protocol for the submission of queries and the publication of these documents.

In this particular case, IEC 60601-1 Interpretation Sheet 3 discusses Subclause 13.1.2, the 4th dash (Emissions, deformation of enclosure or exceeding maximum temperature). The text of the clause is reprinted and then is discussed at length in 4 paragraphs (a little over 1 page). The exact way that the committee intends for uses to meet the clause is reviewed at length to avoid any further confusion over the language in the subclause.

The Interpretation Sheet is 4 pages in length due to the inclusion of the information both in English and in French.

You will want to have the IEC 60601-1 Interpretation Sheets if you use the standard. They will help you avoid errors due to a misreading of the text.

These sheets are available from Document Center Inc. You can request information via a request for quote at our web store, 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 have been assisting customers like you for over 30 years and have a wide variety of services that can improve the way you purchase and use your standards collection. We’d be pleased to become your source for Standards.

Document Center’s 20 Top Selling Standards of 2012

Yes, it’s time to review Document Center‘s top selling standards of 2012. Do you use any of these popular items?

BS EN ISO 13485, New 2012 Edition, Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes
BS EN ISO 14971, New 2012 Edition, Medical Devices. Application of Risk Management To Medical Devices
ISO 15223-1, New 2nd Edition, Medical Devices – Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied – Part 1: General Requirements
BS EN ISO 15223-1 (paper or CD Rom format), New 2012 Edition (replaces BS EN 980), Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied. General Requirements
ASTM F2096, 2011 Edition, Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
AMS 2750, New Revision E, Pyrometry
21 CFR Parts 800-1299, 2012 Edition, Code of Federal Regulations – Title 21–Food and Drugs (Parts 800 To 1299)
ISO 19011, 2011 Edition, Guidelines for Auditing Management Systems
SOR/98-282, 2012 Consolidated Edition, Medical Devices Regulations (Canada)
IEC 60601-1, Consolidated Edition 3.1 with Corrigendum, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
MEDDEV 2.12/1, New 8th Revision, Guidelines on a Medical Devices Vigilance System
ASTM E1417, 2011 Edition with Editorial Change, Standard Practice for Liquid Penetrant Testing
ASTM E18, 2011 Edition, Standard Test Methods for Rockwell Hardness of Metallic Materials
ASTM A370, 2012A Edition, Standard Test Methods and Definitions for Mechanical Testing of Steel Products
IPC-A-610, Revision E, Acceptability of Electronic Assemblies
ISO 11137-2, 2012 Edition, Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose
ASTM A240/A240M, 2012A Edition, Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications
ASQ Z1.4, 2008 Edition, Sampling Procedures and Tables for Inspection by Attributes
ISTA 2A, 2012 Edition, Performance Tests for Packaged-Products, Packaged-Products 150 Lb (68 Kg) or Less
IPC/WHMA-A-620, Revision B, Requirements and Acceptance for Cable and Wire Harness Assemblies — tied with the all time favorite: ISO-9000, 2005 Edition, Quality Management Systems – Fundamentals and Vocabulary

All these standards are available from Document Center Inc. at our webstore, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re here to assist you with both your standards purchases and the services you need to maintain your standards collection.

New Corrigendum 1 (correction sheet) issued for IEC 60601-1 Edition 3.1 consolidated standard on Medical Electrical Equipment

For those of you who use the IEC 60601-1, “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance,” there’s a newly issued correction sheet for the consolidated Edition 3.1 and it’s available now from Document Center Inc. FYI: The Edition 3.1 is an interfiled printing of the 3rd Edition with Amendment 1. The standard is the overview document for the IEC 60601 series on Medical Electrical Equipment.

The Corrigendum 1 is a 2 page correction for Section 7.9.3. It involves changes for 3 symbols, all found in Table D.2 on Safety signs. The Corrigendum includes both the original symbols and titles and the replacement symbols and titles for the 3 rows involved.

You’ll want to have this Corrigendum if you’re using the Edition 3.0 and Amendment 1 separately or using the consolidated Edition 3.1. The changes involved are pertinent for both formats.

Document Center has been selling IEC standards under license agreement since the 1990’s (territorial restrictions apply). You’ll find them in both paper and pdf format at our webstore, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We have been assisting our customers with their standards purchases and questions for over 30 years!

IEC 60601-1 Consolidated Edition 3.1 is now available – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-1, “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance,” is now available from Document Center Inc. in the new consolidated Edition 3.1 — paper or pdf format.

This consolidated version of IEC 60601-1 consists of the third edition (2005), its amendment 1 (2012) and its corrigenda of December 2006 and 2007. The technical content is therefore identical to the 3rd edition and its amendment.

The revision has been prepared for user convenience. A vertical line in the margin shows where the base publication has been modified by amendment 1. Additions and deletions are displayed in red, with deletions being struck through.

By the way, Committee SC62A (the author of IEC 60601-1 ED. 3.1:2012) recognizes that equipment manufacturers and testing organizations may need a transitional period following publication this type of new, amended or revised IEC publication — both to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. Therefore, the Committee recommends that the content of this publication be adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

Document Center Inc. is an authorized distributor of all of the IEC standards. They can be purchased on 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 are always happy to assist you with your standards requirements and questions.

New Amendment 1 for IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-1 Edition 3.0 from 2005, “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance,” has just been modified with the release of the IEC 60601-1-am1. This new 236-page Amendment 1 is available from Document Center Inc. now.

Corrections to the third edition of IEC-60601-1 were initiated to address the way in which risk management has been introduced into IEC 60601-1:2005 and the way the concept of essential performance is used in the standard as well. However, in the end a wide range of modifications have made their way into this update.

The Amendment 1 itself is divided into 2 parts — pages 1 to 114 cover the changes to the English language portion of the standard and pages 115 to the end cover corrections to the French language side. The pen-and-ink changes are extensive and cover the document from stem to stern.

I suspect that because of the importance of this standard, we should see an interfiled Edition 3.1 soon. However, so far there are no indications of when such a revision might be available.

All IEC standards are available under license agreement from Document Center Inc. at our website, www.document-center.com. Or consider contacting us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We can assist you with all your standards questions and requirements.

Why are there so many editions of the Standard 60601-1?

Here at Document Center Inc. we often get asked “What’s the difference between a national or regional adoption of an IEC standard and the original standard itself?” This is a tricky question, since IEC adoptions are not so clear as adoptions of ISO standards at all.

Many national standards are based on IEC documents. However, these standards may contain national deviations which is why the numbering schema for these adoptions is different than for the ISO standards. When an ISO standard is adopted, usually the number becomes the acronym for the country (or region), then the original ISO number complete. For example, the British adoption of ISO 10002 is BS ISO 10002. However the adoption of an IEC standard is just the jurisdiction acronym and the IEC numeric designation, as in IEC 60950-1 and UL 60950-1.

If you’ve done any traveling outside the U.S., you’ll know the wide array of plug adapters, transformers, etc., that you may require to make your electronic devices and appliances work from country to country. The fact that the IEC standards are based on electricity (after all, IEC is the International Electrotechnical Commission) is the reason that the standards often cannot be adopted “as is.”

These jurisdiction-specific deviations include the requirements of a country’s electrical code, conflicting national standards for product types or components, and different component requirements, like modified marking requirements. So a national standards-writing body may decide that the IEC standard can be adopted only by modifying, deleting, or adding requirements.

Determining the differences between the various adoptions of any given IEC standard can be challenging. So to help the user out, often the national adoption will specify in the forward or other area of the document what the specific modifications are.

So for our original IEC 60601-1, the many reprints of the standard all represent potential variations from the original material. Having said that, manufacturers need to design and test their products to the worst-case conditions of the tests that apply to their target markets.

Document Center advises customers to identify all target markets before the design phase is completed and review all IEC standards plus the national adoptions when applicable. Compliance is a critical issue for our customers and one that our wide range of services supports.

Find the standards you need on our website, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Our expert staff can assist with a wide variety of questions and requirements to assure your organization of compliance in today’s competitive marketplace.