New ISO standard available on EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

For those of you in the medical device industry, it can sometimes be difficult to keep up with new releases in your sector.  Here at Document Center Inc., we have a service called Standards Informer that was developed to solve this problem for you.  It monitors new releases and revisions that may affect you and provides you with a quarterly report of these new items.

One new item we’d like to bring to your attention is ISO 14117, “Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices.”   This new release is based on ANSI/AAMI PC69:2007. The relationship between the documents is addressed in Section A.2.4 of the ISO Edition.

ISO 14117:2012 addresses the EM compatibility of pacemakers and ICDs up to 3 000 MHz and is divided in several sections.  They include

  • 0 Hz ≤ ƒ < 450 MHz, the lower-frequency bands
  • 450 MHz ≤ ƒ < 3 000 MHz, the frequencies, ƒ, that are typically associated with personal hand-held communication devices
  • ƒ ≥ 3,000 MHz, testing of devices above 3 GHz is not required.

Technical Committee 150 Subcommittee 6 (Implants for surgery, Active implants) believes it is reasonable to expect that patients with pacemakers and ICDs will be exposed to increasingly complex EM environments. Also, the rapid evolution of new technologies and their acceptance by patients will lead to growing expectations for unrestricted use. Due to the changing EM environment and customer expectations, the subcommittee developed this standard to assist manufacturers with the evaluation process of their product designs to assess compatibility with the complex fields, broad range of frequencies, and variety of modulation schemes associated with existing and future applications.

ISO (and AAMI) standards can be purchased from our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.  We provide standards in both paper and pdf format, with superior notification service support for all purchased documents.

New AS 9131 Revision C, Aerospace Series – Quality Management Systems – Nonconformance Data Definition and Documentation

SAE has just released the new AS 9131, Revision C, “Aerospace Series – Quality Management Systems – Nonconformance Data Definition and Documentation,” and it’s available now from Document Center Inc. in either paper or pdf format.  This standard defines the common nonconformance data definition and documentation that shall be exchanged between an internal/external supplier or sub-tier supplier, and the customer when informing about a nonconformity requiring formal decision.

The requirements are applicable, partly or totally, when reporting a product nonconformity to the owner or operator, as user of the end item (e.g., engine, aircraft, spacecraft, helicopter), if specified by contract. The process of exchanging, coordinating, and approving nonconformance data varies with the multiple relationships and agreements among all parties concerned.

The information provided by AS 9131C forms guidelines for submitting and managing of data through accurate communication. The main objective is to provide the definition of a data set that can be integrated into any form of communication (e.g., electronic data interchange, submission of conventional paper forms).

Reporting of nonconformance data, either electronically or conventionally on paper, is subject to the terms and conditions of the contract. This also includes, where applicable, data access under export control regulations.

All current and many obsolete SAE Standards, including the Aerospace Quality Management Series, are available from Document Center Inc. at our website, www.document-center.com.  Or reach us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We know that you need expert assistance when dealing with standards and our staff has the knowledge to help you.

New ISO 14644-9 available for Cleanrooms and associated controlled environments – Part 9: Classification of surface cleanliness by particle concentration

The ISO 14644 series on Cleanrooms and associated controlled environments has a new addition: ISO 14644-9, 1st Edition, “Cleanrooms and associated controlled environments – Part 9: Classification of surface cleanliness by particle concentration,” and it’s available now from Document Center Inc.  This new part of ISO 14644 provides a classification for the determination and designation of surface cleanliness levels based on particle concentrations. ISO 14644-9:2012 also lists some methods of testing, as well as procedure(s) for determining the concentration of particles on surfaces.

Cleanrooms and associated controlled environments provide for the control of contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of contamination include those in such industries as aerospace, microelectronics, optics, nuclear, and life sciences (pharmaceuticals, medical devices, food, healthcare).

ISO 14644-1 to ISO 14644-8 and ISO 14698-1 and ISO 14698-2 (biological contamination) deal exclusively with airborne particle and chemical contamination. Many factors, besides the classification of surface cleanliness, should be considered in the design, specification, operation and control of cleanrooms and other controlled environments. These factors are covered in some detail in other parts of ISO 14644 and ISO 14698.

Document Center’s new website has listing of Cleanroom Standards that you will want to review.  And use www.document-center.com to order those standards that you need to keep your collection up-to-date.  Or consider contacting us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We can provide you not only with copies of standards in paper or pdf format, but also with the expert information you need to make informed purchasing decisions.

New AWS A5.9/A5.9M 2012 Edition replaces A5.9, Specification For Bare Stainless Steel Welding Electrodes And Rods

The new 2012 Edition for AWS A5.9/A5.9M, “Specification For Bare Stainless Steel Welding Electrodes And Rods,” has been released and is available now from Document Center Inc.  This specification prescribes the requirements for classification of solid and composite stainless steel electrodes (both as wire and strip) for gas metal arc welding, submerged arc welding, and other fusion welding processes. It also includes wire and rods for use in gas tungsten arc welding.

Classification is based on chemical composition of the filler metal. Additional requirements are included for manufacture, sizes, lengths, and packaging. A guide is appended to the specification as a source of information concerning the classification system employed and the intended use of the stainless steel filler metal.

AWS A5.9/A5.9M:2012 makes use of both U.S. Customary Units and the International System of Units (SI). Since these are not equivalent, each system must be used independently of the other.

The previous edition of the document is a 2006 errata reprint.  Prior to that, the 1993 (reapproved in 1999) edition was numbered AWS A5.9 and provided information in U.S. Customary Units only (inch-pound).

All current AWS standards are available 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 have the expertise to assist you with all your standards questions and requirements.

New UL 844 13th Edition is available for Luminaires for Use in Hazardous (Classified) Locations

UL 844, “Standard for Luminaires for Use in Hazardous (Classified) Locations,” has just been issued as the new 2012 13th Edition and is available now from Document Center Inc.  These requirements cover fixed and portable luminaires for installation and use in hazardous (classified) locations — Class I, Divisions 1 and 2, Groups A, B, C, and D; Class II, Division 1, Groups E, F, and G; Class II, Division 2, Groups F and G; and Class III, Divisions 1 and 2, in accordance with the National Electrical Code (NEC), NFPA 70.

These requirements also cover luminaires for installation and use in Class I, Zones 1 and 2, Groups IIA, IIB, IIB plus Hydrogen, and IIC, and Zone 20, 21 and 22 hazardous (classified) locations in accordance with the NEC as well.

ANSI/UL 844 covers luminaires for use only under the following atmospheric conditions:

a) A minimum ambient temperature of minus 25°C (minus 13°F);

b) An oxygen concentration not greater than 21 percent by volume; and

c) A nominal barometric pressure of one atmosphere.

This new 110-page 13th Edition includes the following changes in requirements:

Revisions for Test Paint for Spray Booth Luminaires

Revisions for Temperature Tests at Elevated Ambient Temperatures

Correction of Referenced Section Title in Paragraph 74.3

Clarification of Required Number of As-Received Samples of Polymeric Enclosure Materials

All current UL standards are available from Document Center Inc.’s website, www.document-center.com, under license agreement with UL.  If you have any additional questions, contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here to assist you with all your standards questions and requirements.

New ASTM B339 2012 Edition – Specification for Pig Tin

There’s a new 2012 Revision for the widely-used ASTM A339, “Standard Specification for Pig Tin,” and it’s available now from Document Center Inc.  This 4-page specification covers refined tin in pig form recovered and cast from primary and secondary tin-bearing materials.

One grade of tin metal is specified and is designated as Grade A. The refined tin is produced from primary, secondary, or a combination of tin-bearing materials to obtain the requirements of this specification, and may be manufactured by fire refining, vacuum refining, electrolytic or electrowinning refining methods, or a combination of the above.

The metal shall conform to the chemical composition requirements prescribed for tin, antimony, arsenic, bismuth, cadmium, copper, iron, lead, nickel, sulfur, zinc, silver, and other impurities. All tin of Grade A produced and cast at one time shall constitute a lot for chemical analysis.

Sampling for chemical analysis are specified as one of the following methods: (1) sampling from the lot during casting, and (2) sampling from the solidified cast pig product by sawing, drilling, or melting. The methods of sampling cast pig product are illustrated.

If product analysis is desired, it may be made by methods including, but not limited to, wet chemical or spectrographic techniques.

ASTM B339-12, as well as all current and many obsolete revisions of ASTM standards, may 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).  Many ASTM documents have red-line editions available as well, which provide you with a second copy that includes markup for all changes from the previous edition.  Our website will show you when a red-line edition is available for a particular standard, and our staff can assist you too.

New CLSI GP17 3rd Edition on Clinical Laboratory Safety

CLSI has just released the new 3rd Edition for GP17, “Clinical Laboratory Safety,” and it’s available now from Document Center Inc. This 104-page Approved Guideline contains general recommendations for implementing a high-quality laboratory safety program, which are provided in a framework that is adaptable within any laboratory.

CLSI GP17 A3 is written for laboratory staff who are responsible for developing and implementing a safety program. Aspects of a safety program addressed in this guideline include maintenance and inspection, personal safety, and warning signs and labels. The guideline also addresses fire prevention, electrical and radiation safety, and other potential laboratory hazards.

Known formerly as NCCLS, the Clinical and Laboratory Standards Institute (CLSI) standards are available from Document Center Inc. in paper format and can be ordered 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 monitor standards daily in order to provide you with the latest information on the documentation you use in your business.

New AAMI SW87 provides guidance for Application of Quality Management System concepts to Medical Device Data Systems (MDDS)

The new AAMI SW87, “Application of Quality Management System concepts to Medical Device Data Systems (MDDS),” has been released and is now available from Document Center Inc.

To ensure the safety and effectiveness of medical device data systems (MDDSs), regulators like the U.S. Food and Drug Administration are requiring organizations that develop or provide medical device data systems to implement a quality management system.

This 38-page recommended practice provides information that allows the medical device data system manufacturer to implement a quality management system that matches the risk presented by the device, the complexity of device and manufacturing processes, and the size and complexity of organization.

Right now, the new ANSI/AAMI SW87:2012 is only available in pdf format, but should be released in paper format from the publishers soon.  You can purchase a copy on our website, www.document-center.com.  Or contact us for more information by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We appreciate the chance to help you with your standards requirements and questions.

New ISO 8600-7 2012 1st Edition released for Endoscopes – Medical endoscopes and endotherapy devices – Part 7: Basic requirements for medical endoscopes of water-resistant type

ISO has just released the new ISO 8600-7:2012, “Endoscopes – Medical endoscopes and endotherapy devices – Part 7: Basic requirements for medical endoscopes of water-resistant type,” and it is available now from Document Center Inc.   This part of ISO 8600 specifies requirements for medical endoscopes, either flexible or rigid with a bending section, of the water-resistant type.

The new 6-page ISO 8600-7 is part of the ISO 8600 series, which defines terms and gives requirements for endoscopes and endotherapy devices used in the practice of medicine.

The other documents that comprise this series are:

—  ISO-8600-1:2005, Optics and photonics — Medical endoscopes and endotherapy devices — Part 1: General requirements,
— ISO-8600-2:2002, Optics and optical instruments — Medical endoscopes and endoscopic accessories — Part 2: Particular requirements for rigid bronchoscopes,
— ISO-8600-3:1997 with Amendment 1 from 2003, Optics and optical instruments — Medical endoscopes and endoscopic accessories — Part 3: Determination of field of view and direction of view of endoscopes with optics,
— ISO-8600-4:1997, Optics and optical instruments — Medical endoscopes and certain accessories — Part 4: Determination of maximum width of insertion portion,
— ISO-8600-5:2005, Optics and photonics — Medical endoscopes and endotherapy devices — Part 5: Determination of optical resolution of rigid endoscopes with optics and
— ISO-8600-6:2005, Optics and photonics — Medical endoscopes and endotherapy devices — Part 6: Vocabulary.

All current ISO standards and many obsolete versions are available 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).  We offer standards sales and support to the medical device industry, providing a wide range of documentation not available from other standards organizations.

New ASTM E165/E165M 2012 Edition is available on Liquid Penetrant Testing

For those of you who do liquid penetrant testing, you’ll want to know that there’s a new 2012 Edition of the ASTM E165/E165M standard, “Standard Practice for Liquid Penetrant Examination for General Industry.”  The new 18-page standard is available from Document Center Inc. in paper and pdf format, and a redline edition can also be purchased which includes the markup so you can identify all the new changes.

ASTM E165/E165M-12 covers procedures for penetrant examination of materials. Penetrant testing is a nondestructive testing method for detecting discontinuities that are open to the surface such as cracks, seams, laps, cold shuts, shrinkage, laminations, through leaks, or lack of fusion and is applicable to in-process, final, and maintenance testing.

It can be effectively used in the examination of nonporous, metallic materials, ferrous and nonferrous metals, and of nonmetallic materials such as nonporous glazed or fully densified ceramics, as well as certain nonporous plastics, and glass.

The standard was previously numbered ASTM E165.  The new designation (E165/E165M) means that that whereas the values used to be stated in inch-pound units and SI units were provided for information only, now values stated in either SI units or inch pound units are to be regarded separately as standard.

All current ASTM standards, and many obsolete ones as well, are available 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).  We have 30 years of experience in assisting people like you with standards questions and requirements.