MIL-PRF-13830 Validated – Optical Components for Fire Control Instruments

MIL-PRF-13830B, “Optical Components for Fire Control Instruments; General Specification Governing the Manufacture, Assembly, and Inspection of,” has been validated.  The document and/or the validation notice are available now from Document Center Inc. in either paper or pdf format.  This is one of our most popular optical specifications.

This specification covers the manufacture, assembly, and inspection of finished optical components such as lenses, prisms, mirrors, reticles, windows and wedges for fire control instruments.

The document was originally numbered MIL-O-13830.  Due to Mil Spec reform in the 1990’s, the number was changed to MIL-PRF-13830 with the release of Revision B in 1997.  This change in designation confirmed that the specification is a performance document, based on performance criteria rather than specific requirements.

The document was cancelled, but then reactivated in 2000.  This points out the value of continuing to monitor cancelled documents in your standards collection — One never knows when industry or caretaker concerns will prompt the repeal of a cancellation.

The Validation Notice 3 that was issued on 3/14/2013 verifies that the document has been reviewed and is still valid for procurement.  You may need the notice if your auditor is particularly detail oriented.  Otherwise, if you are only interested in the technical information, the validation notice does not contain any changes to the document itself.

All current and publicly available Mil Specs and Standards (as well as many obsolete editions) are available in 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 supporting the Defense Industry since 1982 and can assist you with all your conformance documentation requirements.

New ARP 5412 and ARP 5416 Updates available for Aircraft Lightning Tests

New Revisions have recently been released for two important SAE aircraft lightning test practices, ARP 5412 and ARP 5416.   They are available now from Document Center Inc. in either paper or pdf format.  The two documents are critical to evaluating lightning susceptibility in aircraft.  They are ARP 5412 Revision B, “Aircraft Lightning Environment and Related Test Waveforms,” and ARP 5416 Revision A, “Aircraft Lightning Test Methods.”

ARP 5412B defines environment and test waveforms using the best lightning data and analysis currently available.  It was released to update the certification lightning environment and to address various issues brought up by members of the aerospace community.  Areas modified include the lightning parameter information and standards waveforms.

Within this document, standardized voltage and current waveforms have been derived to represent the lightning environment external to an aircraft. These standardized waveforms are used to assess the effects of lightning on aircraft.

ARP 5416A on the other hand is a compilation of test methods which have been updated to reflect the need for clarification to ensure consistency across test organizations, particularly with regards to high voltage tests and integrated system functional upset tests.  Also, originally some methods relied on the use of Polaroid film which is becoming obsolete, so photographic methods using modern camera technologies have been included in this revision.

This document describes how to conduct lightning direct effects tests and indirect system upset effects tests.  It presents test techniques for simulated lightning testing of aircraft and the associated systems.  Each test method is set out in a uniform format, describing the test purpose, test object, test setup, test waveforms (voltage and/or current), measurements and data recording, test procedure and data interpretation.  Guidance is provided on how to select the appropriate test or series of tests, and how the test results can be assessed.

You may also find these standards to be of interest:

  • RTCA-DO-160, Environmental Conditions and Test Procedures for Airborne Equipment
  • MIL-STD-461, Requirements for the Control of Electromagnetic Interference Characteristics of Subsystems and Equipment
  • MIL-STD-464, Electromagnetic Environmental Effects Requirements for Systems
  • IEC 61000-4-5, Electromagnetic Compatibility (EMC) – Part 4-5: Testing and Measurement Techniques – Surge Immunity Test

All SAE standards, including many obsolete editions, can be purchased at Document Center’s 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 expert staff available for you to assist with both standards purchases and the various questions and support services that the use of this compliance information requires.

New AAMI TIR29 2012 Edition just released – Guide for process control in radiation sterilization

AAMI TIR29, “Guide for process control in radiation sterilization,” has just been released and is available in either paper or pdf format from Document Center Inc.  This technical information report provides additional guidance for characterizing the irradiation process and for establishing requisite process controls to ensure the irradiation system remains in a validated state.

This document is intended to complement qualification and routine control activities as defined in ANSI/AAMI/ISO 11137 for gamma, X-ray, and electron beam sterilization.

This document is the second edition of AAMI TIR29.  It is now more closely aligned with the general format/section headings of ISO 11137-1 and eliminates redundancies of ISO 11137-3. This second edition is expanded to encompass process characterization and process control, address X-ray sterilization, and provide more guidance regarding additional dose mapping studies, mapping, and processing families. It also incorporates information regarding process equivalency in cobalt-60 radiation sterilization facilities.

The new 28-page 2012 Edition replaces AAMI TIR29 2002, which is now obsolete.  In spite of the fact that it is aligned with the ISO 11137 series, there is no equivalent International Standard for this AAMI release. The document is cited by the FDA as relevant guidance.

All current and many obsolete AAMI standards are available from Document Center Inc. under license agreement.  AAMI documents can be purchased 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 provide documentation sales and support services to many medical device manufacturers and can help you with your compliance requirements.

New MIL-HDBK-502 Revision A, Product Support Analysis

MIL-HDBK-502 Revision A, “Product Support Analysis,” has just been released and is now available from Document Center Inc. in either paper or pdf format.  This handbook addresses the overall Product Support Analysis (PSA) process and its associated activities, the selection and tailoring of those activities to meet DoD program supportability objectives, and sample contract language for acquiring PSA deliverables.

The 104-page handbook offers guidance on TA-STD-0017, PSA activities as an integral part of the overall systems engineering process. The information the handbook is applicable to all types of materiel and automated information systems and all acquisition strategies. The focus is to provide guidance to the members of the defense acquisition workforce who are responsible for the supportability of materiel systems or automated information systems.

Like all handbooks, MIL-HDBK-502A is for guidance only and cannot be cited as a requirement.  Changes from the original release in 1997 are extensive, so there’s no markings in the margins for guidance.

All Mil Specs and Standards can be purchased from the Document Center website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been working with DoD documents since 1982 and can assist you with all your documentation requirements.

Two New Revisions for ASTM Zinc Specs, ASTM B6 and ASTM B240

There’s two new ASTM revisions for zinc specifications, ASTM B6 and ASTM B240.  The two standards are ASTM B6-13, “Standard Specification for Zinc,” and ASTM B240-13, “Standard Specification for Zinc and Zinc-Aluminum (Za) Alloys in Ingot Form for Foundry and Die Castings.”

ASTM B6 covers zinc metal made from ore or other material by a process of distillation or by electrolysis in five grades as follows: LME grade, special high grade, high grade, intermediate grade, and prime western grade. The zinc metal is tested and conforms to the chemical composition requirements of lead, iron, cadmium, aluminum, copper, tin, and non-zinc metals.

The B6 2013 Edition replaces the 2012 release, which is now obsolete.  For the new edition, UNS numbers were added.

ASTM B240 covers commercial zinc and zinc-aluminum alloys in ingot form for remelting for the manufacture of pressure die castings, foundry castings and continuous cast bar stock. Seven alloy compositions are specified, which includes Z33521, Z33522, Z35530, Z35540, for zinc alloys and Z35635, Z35630, Z35840, for zinc-aluminum alloys. The material is expected to be of uniform quality and reasonably free from dross, adhering foreign matter, and surface oxide.

The 4-page B240 2013 Edition replaces the 2010 release, which is also now obsolete.  And again, the UNS numbers were added.

Both ASTM B6 and ASTM B240 were released 3/15/2013 and can be purchased at Document Center’s webstore, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  In additional to providing you with a premium resource for purchasing your conformance information, we’re here to assist you with all your questions about standards.

New ISO 14644 Series Standards released for Cleanrooms

ISO has just released two new standards in the ISO 14644 Series on Cleanroom – ISO 14644-10:2013 and ISO 14644-8:2013 – and they’re available now from Document Center Inc.  The first is a Second Edition for ISO 14644-8, “Cleanrooms and associated controlled environments – Part 8: Classification of air cleanliness by chemical concentration (ACC).”   The second new standard, ISO 14644-10, 1st Edition, is titled “Cleanrooms and associated controlled environments – Part 10: Classification of surface cleanliness by chemical concentration.”

ISO 14644-8:2013 establishes the classification of air chemical cleanliness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category) and provides a protocol to include test methods, analysis and time-weighted factors within the specification for classification.

The new revision currently considers only concentrations of air chemical contaminants between 100 and 10−12 g/m3 under cleanroom operational conditions.

It is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process.

ISO 14644-10:2013 defines the classification system for cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles).

It is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environment, tools, equipment and devices.  It complements the other sections of the standard, which are listed below:

  • 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
  • ISO 14644-3, Cleanrooms and Associated Controlled Environments – Part 3: Test Methods
  • ISO 14644-4, Cleanrooms and Associated Controlled Environments — Part 4: Design, Construction and Start-Up
  • ISO 14644-5, Cleanrooms and Associated Controlled Environments – Part 5: Operations
  • ISO 14644-6, Cleanrooms and Associated Controlled Environments – Part 6: Vocabulary
  • ISO 14644-7, Cleanrooms and Associated Controlled Environments – Part 7: Separative Devices (Clean Air Hoods, Gloveboxes, Isolators and Mini-Environments)
  • ISO 14644-9, Cleanrooms and Associated Controlled Environments – Part 9: Classification of Surface Cleanliness by Particle Concentration

For listings of more cleanroom standards, see Document Center’s website pages  Popular Cleanroom Standards and ESD (Electrostatic Discharge Control) Standards.

FYI: An additional Part 12 is being prepared by ISO Technical Committee 209, so there should be another issue available shortly.

ISO standards can be purchased at Document Center’s webstore, www.document-center.com.  Both current and obsolete editions are available, but some territorial restrictions do apply.  Or consider getting in touch with us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been here for over 30 years, helping customers just like you with all their conformance documentation requirements.

New ISO 8600-1 2013 Edition issued for Endoscopes

There’s a new 3rd Edition out for ISO 8600-1, “Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements,” and it’s available now from Document Center Inc.  The widely used Medical Device standard ISO 8600-1:2013 provides the user with definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.  FYI: The second edition is now obsolete.

There are a total of 7 parts in this series.  The others are:

  • ISO 8600-2, Optics and Optical Instruments – Medical Endoscopes and Endoscopic Accessories – Part 2: Particular Requirements for Rigid Bronchoscopes
  • ISO 8600-3, 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, Optics and Optical Instruments — Medical Endoscopes and Certain Accessories — Part 4: Determination of Maximum Width of Insertion Portion
  • ISO 8600-5, Optics and Photonics – Medical Endoscopes and Endotherapy Devices – Part 5: Determination of Optical Resolution of Rigid Endoscopes With Optics
  • ISO 8600-6, Optics and Photonics – Medical Endoscopes and Endotherapy Devices – Part 6: Vocabulary, and
  • ISO 8600-7, Endoscopes – Medical Endoscopes and Endotherapy Devices – Part 7: Basic Requirements for Medical Endoscopes of Water-Resistant Type

All ISO standards are sold at our Document Center webstore, www.document-center.com (some territorial restrictions may apply).  Or you can contract us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We look forward to working with you.

ISO 19001 2013 Edition for Manufacturer’s info for In vitro diagnostic reagents

ISO 19001 2013 Edition has just been released.  The document, titled “In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology,” specifies requirements for information supplied by the manufacturer with reagents used in staining in biology.  It’s the 2nd Edition and is a technical revision of the 1st Edition which is now obsolete.

The standard applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in histology and cytology including bacteriology, haematology, histochemistry, as performed in medical laboratories, both routine and research bacteriology.

The requirements for information supplied by the manufacturer specified in ISO 19001 are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.

The standard may be used with ISO 18113-1, “In Vitro Diagnostic Medical Devices – Information Supplied by the Manufacturer (Labelling) – Part 1: Terms, Definitions and General Requirements” and ISO 18113-2, “In Vitro Diagnostic Medical Devices – Information Supplied by the Manufacturer (Labelling) – Part 2: in Vitro Diagnostic Reagents for Professional Use.”

All ISO standards are available from Document Center Inc.  You can order on our website, www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We appreciate your business!

New ISO 5840-3 2013 Edition – Heart valve substitutes

ISO 5840-3 2013 Edition, “Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques,” has just been released.  Available now from Document Center, the standard outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management.

The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

This new ISO 5840-3 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

ISO 5840-3  is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute.

It can be used for both newly developed and modified transcatheter heart valve substitutes and to the accessory devices, packaging and labeling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.

FYI: There are two additional parts that are in process:

  • ISO 5840-1, Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements, and
  • ISO 5840-2, Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted valve substitutes

Purchase this and all current (as well as many obsolete) ISO standards at Document Center’s 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 all your documentation requirements.

New AMS DTL 22499 Revision A released for Laminated Shim Stock

There’s a new AMS DTL 22499A, “Shim Stock, Laminated,” and it’s available now from Document Center Inc. in either paper or pdf format.  This specification covers the requirements for surface bonded laminated shim stock.  Revision A is a technical revision and replaces the original 1998 publication.

The standard is a good example of the long and winding road some documents go down!  Originally, the specification was number MIL-S-22499, “Shim Stock, Laminated.”  With Mil Spec Reform in the 1990’s it was renumbered MIL-DTL-22499 to reflect the fact that it is a detail specification — One that depends on a precise definition for compliance.

However, in 1998 SAE took over the care-taking responsibilities for the document, leading to yet another renumbering — This time to AMS DTL 22499. This means that the document is now a private industry Aerospace Material Specification, rather than a public Military Specification.

There are also “Slash Sheets” available for this item:

You can purchase both Mil Specs and AMS documents in paper and pdf format from Document Center 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 can help you find the documents you need, even when things like numbering changes make your search difficult.