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New ISO/TS 17665-3 released for Steam Sterilization of Medical Devices

Tuesday, May 21st, 2013

A new technical specification, ISO/TS 17665-3, “Sterilization of health care products – Moist heat – Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization,” has just been issued.  You can buy the ISO/TS 17665-3 from Document Center Inc. in paper format or to download as a pdf copy.  The new specification is the 3rd part in this series on efficient sterilization of medical devices and is meant to be used with Parts 1 and 2.

In most health care facilities, sterilization of medical devices and health care products is done by the steam sterilization method.  It consists of three distinct stages:  air removal, sterilizing and drying.

This standard is  intended to assure sterilization when multiple products are processed at the same time.   This “sterilization load” is made safe by processing product families that have been pre-screened using the ISO/TS 17665-3 standard methodology.

ISO/TS 17665-3 helps the user define the attributes of the device for assigning a product family category for the moist heat sterilization process.  These attributes have been chosen based on operation experience, engineering considerations and experimental data.  They rely on the types and designs of differing medical devices and sterile barrier and/or packaging systems.

The three documents that make up the series are:

  1. ISO 17665-1:2006, Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
  2. ISO/TS 17665-2:2009,  Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1, and
  3. ISO/TS 17665-3:2013, Sterilization of health care products – Moist heat – Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization

You can purchase ISO standards, both current editions and many obsolete revisions, at Document Center’s web store, www.document-center.com.  Or you can reach us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re Your Standards Experts and we’re here to make sure you have the standards you need to run your business effectively.

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New ASTM C1009 2013a Edition released for Nuclear Industry Labs

Monday, May 20th, 2013

We’ve just received the new ASTM C1009 2013a Edition, “Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry.”  Now you can buy it in either paper or pdf format from Document Center Inc.  The Guide covers the establishment and maintenance of a quality assurance (QA) program for analytical laboratories within the nuclear industry.

These types of labs provide services for many types of applications, including geological prospecting, environmental contamination survey or biomedical investigations.  The ASTM C1009 is part of an international effort to assure  customers of these labs that the results of any given analysis is globally recognized in order to facilitate to movement of goods in cross-border trade.

So while the Guide does not have the language that supports manditory adherence to its various clauses, an analytical lab of this type must meet stringent requirements for each of the elements addressed in the document.  These elements are Organization, Quality Assurance Program, Training and Qualification, Procedures, Lab Records, Control of Lab Records, Control of Procurement, Control of Measuring Equipment and Material, Control of Measurements, and lastly, Deficiencies and Corrective Actions.

ASTM C1009-13a is one of 4 core documents for quality assurance in laboratories that provide quality analyses on nuclear fuel cycle materials.  The other three standards are the ISO 9001, of course, ISO/IEC 17025 and ASME NQA-1, which has also been recently updated.  Table X1.1 cross-references the requirements of all 4 publications.

You can buy all ASTM standards, as well as the other documents mentioned, at Document Center’s web store, 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 selling standards since 1982 and can assist you with all your standards requirements and questions.

 

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New ASTM F2989 covers Unalloyed Titanium Components Used for Surgical Implants

Friday, May 17th, 2013

There’s a new ASTM F2989 2013 Edition, “Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications,” and it’s available now in paper or pdf format from Document Center Inc.  The document covers the chemical, mechanical and metallurgical requirements for three grades of metal injection molded unalloyed titanium components to be used in the manufacture of surgical implants.

The metal injection molded (MIM) titanium in ASTM F2989-13 makes use of 2 types as well as the 3 grades.  The chemical composition matches up to ASTM F67 except for the maximum oxygen level of Grade MIM 3.

The standard provides for both the use of SI (preferred) and inch-pound units without the use of the ASTM F2989/F2989M designator.  This is because ASTM is in the process of implementing a migration path that should culminate with total reliance on SI units by 2018.

Another thing to note in ASTM F2989 is the Appendix X2 on biocompatibility.  It is informational and provides the user with a basis for evaluating the level of biological response to be expected when using this material.  Appendix X1, Rationale, includes the purpose; chemistry, process history and mechanical properties; fatigue; binders; and units of measurement.

ASTM F2989 was developed not only for manufacturers and medical device companies, but also to serve as a basis for certification by testing laboratories and as a guideline for regulatory bodies.  It supports the design of new shapes and allows MIM components to be directly compared to parts made by more conventional methods.

You can order ASTM Standards in both paper and pdf format from Document Center at our web store, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We are your Standards Experts and we’re here to help you keep your conformance documentation complete and current.

 

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MIL-DTL-22520 Group Cancellation issued for Crimping Tools

Thursday, May 16th, 2013

A group cancellation notice has been issued for MIL-DTL-22520 and four  of it’s slash sheets.  The documents are all for wire termination crimping tools and all have been replaced by the AS 22520 editions of the same specifications.  Both the obsolete Mil specs and the replacement AS documents can be purchased from Document Center Inc. in both paper and pdf format.

Here’s the details:

  • MIL-DTL-22520, Revision G, “Crimping Tools, Wire Termination, General Specification for,” has been withdrawn in favor of AS 22520, same title, issued by SAE in 2011
  • MIL-C-22520/17 Revision B, “Crimping Tools, Terminal, Hand, Wire Termination for Crimp Type Removable Contacts, Electric Connectors,” has been withdrawn in favor of AS 22520/17, again same title and again issued in 2011
  • MIL-DTL-22720/38, “Crimping Tool, Terminal, Hand Actuated, Wire Termination, Type II, for External Power Plug Socket Contacts and Lug Terminal Sizes 22-10,” has been withdrawn and replaced by AS 22520/38, same title, same year.
  • MIL-DTL-22720/40, “Crimping Tools, Terminal, Hand, Wire Termination; Type II T-Head for Terminal Lugs and Splices Size 22-14,” has been withdrawn in favor of AS 22520/40, same title, issued in 2012.
  • MIL-DTL-22720/41, “Crimping Tools, Terminal, Hand, Wire Termination; Type II for Terminals and Splices Size 10-14,” replaced by AS 22520/41, with the same title and issued in 2012 as well.

FYI: The DoD has issued a notice of adoption for each of the AS replacement documents.  This adoption notice states that the industry standard has been reviewed and is authorized for use in military contracts.

It is typical in these cases for the latest edition of the military document to be reprinted as is, with modifications made to meet the differing SAE format requirements.  Over time, the AS reprints may be revised and that signals the participation of the DoD in the committee process itself.

Purchase your copies of these specifications at Document Center’s web store, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) to learn more about these items.  We’ve been reselling both collections since the 1980′s and have the expertise to assist you with any requirements you may have.

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New IEEE 4 2013 Edition for High Voltage Testing Techniques

Wednesday, May 15th, 2013

There’s a new IEEE 4, “IEEE Standard for High-Voltage Testing Techniques,” that’s just been released and it’s available now from Document Center Inc. in either paper or pdf format.  The standard is one of the oldest titles in the IEEE collection, with the first edition dating back to 1928.  This new 2013 update is the 8th Edition.

IEEE 4-2013 establishes standard methods and basic techniques for high-voltage testing. The standard is applicable to all types of apparatus for alternating voltages, direct voltages, lightning impulse voltages, switching impulse voltages, and impulse currents.  It is applicable only to tests on equipment with a rated voltage above 1000 V.

IEEE 4 is intended to define terms of general applicability, provide general requirements for test equipment and procedures, and to describe various methods for the evaluation of the test results.  You’ll find procedures for applying correction factors to convert test data to standard atmospheric conditions.  And methods are supplied for testing equipment when external insulation of the test object is to be subjected to dry, wet, or contaminated conditions.

There is no guidance in the document itself for determining exactly where changes have been made.  However, the revision has reorganized the technical content so that the sections that deal with alternating voltage, direct voltage, and impulse voltage testing are grouped together.  Also, it introduces the concept of measurement uncertainty in evaluation of high-voltage and high-current tests.

The previous 7th Edition was released in 1995 and is made obsolete by the release of the 2013 revision.

All IEEE standards are available from Document Center’s web store, www.document-center.com, in either paper or pdf format.  We carry both current and obsolete editions.  If you prefer, contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’d be happy to assist you with all your conformance documentation requirements.

 

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New Revisions Released for MIL-STD-750 series

Tuesday, May 14th, 2013

MIL-STD-750, “Test Methods for Semiconductor Devices,” and several of it’s subsections have recently been updated.  The new issues are available now from Document Center Inc.  in both paper and pdf format.  Compliance with the changes is expected to be completed by June 13, 2013.

MIL-STD-750F is modified by the new Change 1.  It is the overview document for the series which establishes uniform test methods for testing the environmental, physical, and electrical characteristics semiconductor devices.  The change notice adds paragraph 4.1.3, to define acceptable international sinusoidal pulse input wave frequency.

MIL-STD-750-1 covers Environmental Tests 1000 through 1999.  The change notice 1 is more extensive, modifying paragraphs 13, 13.1.1, 13.1.2, and 13.2.1 (all part of Test Method 1071).

For MIL-STD-750-2, Mechanical Test Methods 2001 through 2999, the new update is Change 3.  This change modifies several test method in order to bring them in line with MIL-STD-883.  The test methods that have been changed are 2006 (paragraph 3), 2056 (paragraph 3.2.2), and 2057 (paragraphs 3.3 and 3.4).

All of these updates are released as interfiled editions.  This means that the standard plus all changes is republished in 1 document, with the changed language already included.  It is helpful in that the user doesn’t have to make the changes by hand, but it can sometimes make the identification of changes more difficult.  In the case of the MIL-STD-750 series, the summary of changes at the beginning of the revised documents is most helpful.

MIL Standards and Specifications can all be purchased from Document Center Inc. in paper or pdf format at our webstore, www.document-center.com.  Or consider reaching 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 requirements for keeping your compliance collection complete and correct.  We’re your Standards Experts!

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EN 1760-1 and EN 1760-2 replaced by ISO 13856 adoptions

Monday, May 13th, 2013

If you use EN 1760-1, “Safety of machinery. Pressure sensitive protective devices. General principles for the design and testing of pressure sensitive mats and pressure sensitive floors,” or EN 1760-2, “Safety of machinery. Pressure sensitive protective devices. General principles for the design and testing of pressure sensitive edges and pressure sensitive bars,” the documents have been withdrawn.  You’ll want to replace your copies with the EN adoptions of ISO 13856-1 and ISO 13856-2 respectively.  They’re available now from Document Center Inc.

The new adoptions are:

  • BS EN ISO 13856-1:2013, “Safety of machinery. Pressure-sensitive protective devices. General principles for design and testing of pressure-sensitive mats and pressure-sensitive floors.”  The new adoption establishes general principles and specifies requirements for the design and testing of pressure-sensitive mats and pressure-sensitive floors normally actuated by the feet for use as devices for protecting persons from hazardous machinery. The minimum safety requirements for the performance, marking and documentation are given.
  • BS EN ISO 13856-2:2013, “Safety of machinery. Pressure-sensitive protective devices. General principles for design and testing of pressure-sensitive edges and pressure-sensitive bars.”  This standard is applicable to pressure-sensitive edges and pressure-sensitive bars, with or without an external reset facility, used to detect persons or body parts that can be exposed to hazards such as those caused by the moving parts of machines.

EN 1760-3 remains current.

The source standards, ISO 13856-1 and ISO 13856-2, were both revised this year.  They are classified as Type-B2 standards on safeguards (e.g. two hand controls, interlocking devices, pressure sensitive devices, guards).  It is not clear from a reading of the two ISO standards how they were modified to accommodate adoption as European Standards.

All current ISO and BS EN standards can be purchased under license agreement from Document Center’s web store, www.document-center.com.  Or feel free to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We are able to assist you with your questions and requirements for the compliance documentation you need to use in your business.

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New ISO 13408-1 and ISO 13408-6 Amendments released for Aseptic Processing for Health Care Products

Friday, May 10th, 2013

The ISO 13408 series covers sterilization of health care products, including medical devices, that cannot be terminally sterilized (sterilization in the final sealed container).  For these types of products the use of aseptic handling, filling, transfer and packaging may be required to insure the safe delivery of a product to a customer.

Two amendments have been released for standards in the series:  Amendment 1 for ISO 13408-1 2008 (2nd) Edition, “Aseptic Processing of Health Care Products – Part 1: General Requirements,” and Amendment 1 for ISO 13408-6 2005 (1st) Edition, “Aseptic Processing of Health Care Products – Part 6: Isolator Systems.”  If you use either of these standards, it is critical that you get the new amendments right away.  They are sold separately from the standards and they’re available now from Document Center Inc.

Amendment 1 for ISO 13408-1 contains 5 pages of corrections, termed “pen and ink” changes.  These are minor but extensive changes to the standard that need to be met by the user.  Most can be inserted into your copy of the 2nd edition by hand, however one of the tables (Figure A.1) will need to be replaced in it’s entirety.

Amendment 1 for ISO 13408-6 contains 4 pages of similar corrections.  It makes changes to the foreword and to pages 1, 2, 3, 4, 6, 8, 9, 10, 11, 13, 14, 15 and 17.  Get out your pen!

Here’s a list of all the standards that make up the ISO 13408 series:

  • ISO 13408-1:2008, Aseptic processing of health care products — Part 1: General requirements
  • ISO 13408-2:2003, Aseptic processing of health care products — Part 2: Filtration
  • ISO 13408-3:2006, Aseptic processing of health care products — Part 3: Lyophilization
  • ISO 13408-4:2005, Aseptic processing of health care products — Part 4: Clean-in-place technologies
  • ISO 13408-5:2006, Aseptic processing of health care products — Part 5: Sterilization in place
  • ISO 13408-6:2005, Aseptic processing of health care products — Part 6: Isolator systems
  • ISO 13408-7:2012, Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products

You can purchase all current and many obsolete ISO standards from your authorized dealer, Document Center Inc., at our web store: 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 provide you with the services you need to keep your standards collection complete and correct!  We’re your Standards Experts.

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New ANSI/ASSE A10.9 2013 on Safety Requirements for Masonry and Concrete Work

Thursday, May 9th, 2013

ANSI/ASSE A10.9 2013 Edition, “Safety Requirements for Masonry and Concrete Work,” has just been released and is available from Document Center Inc. in either paper or pdf format.  The document is one of the American National Standards for Construction and Demolition Operations.

ANSI/ASSE A10.9 establishes safety requirements pertaining to concrete construction and masonry work in construction. The requirements cover all on-site concrete construction and masonry work including design, erection, operation and maintenance of aggregate processing plants, concrete mixing plants and conveyances. It also contains safety requirements regarding the specialty concrete operations of prestressing by pretensioning or post-tensioning, lift-slab construction, tilt-up construction and slipforms.

The new ANSI A10.9 2013 Edition was released to update the information relating to reinforcing steel and post-tension operations.  It is intended to help industry meet new Occupational Safety and Health Administration (OSHA) standards.  ASSE, the American Society of Safety Engineers, has put in a request to OSHA to have the references in  title 29 CFR Part 1926 (Safety and Health Regulations for Construction) updated to include this new edition of the standard, which replaces all previous editions.

All ASSE standards are available from Document Center’s web store, www.document-center.com.  They are sold in both paper and pdf format under license agreement with ASSE.  Should you prefer, you are welcome to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts and we’re here to assist you with all your compliance documentation requirements.

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New SAE J429, Mechanical and Material Requirements for Externally Threaded Fasteners

Wednesday, May 8th, 2013

SAE has released a new 2013 edition of SAE J429, “Mechanical and Material Requirements for Externally Threaded Fasteners,” and you can purchase it now from Document Center Inc. in both paper and pdf format.  The Ground Vehicle Standard covers the mechanical and material requirements for inch-series steel bolts, screws, studs, screws for sems (screw and washer assemblies), and U-bolts in sizes to 1-1/2 in. inclusive.

FYI: The U-bolts in SAE J429 2013 are used predominantly in the suspension and related areas of vehicles.  They are treated like studs in this document.  SAE recommends that designers using this standard review the actual load-carrying capacity of them with saddle load tests.

The studs in this standard are cylindrical rods of moderate length, threaded on either one or both ends, or even throughout the entire length of the stud.  Any products that use a head, collar, or something similar are referred to as bolts.  Table 2 covers the chemical composition requirements.

The 2013 Edition is a revision of the previous J429 released in September of 2009.  The new edition replaces all previous editions, which are now obsolete.

SAE standards and specifications can all be purchased at Document Center’s web store, www.document-center.com.  Or you can reach us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We sell the documents under license agreement with SAE and can provide you with on-going support with notification and reporting services.

For more information on new releases, please check in with Document Center’s new blog, blog.document-center.com.  It is a welcome addition to the informational services provided by our company.

 

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