New ASTM F86 2012 Edition on Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

ASTM F86 2012 Edition, “Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants,” has just been released and is now available in paper or pdf format from Document Center Inc.   The surface treatments documented in this practice are intended to improve the corrosion resistance of metallic surgical implants manufactured from iron, cobalt, titanium, and tantalum base materials.

Iron particles, ceramic media, and other foreign particles may become smeared over or imbedded into the surface of implants during processing operations such as forming, machining, tumbling, bead blasting, and so forth. These particles should be removed to minimize localized rust formation and superficial blemishes.

The need for an additional implant surface treatment such as secondary passivation in nitric acid should be evaluated for localized implant surfaces that have electrochemical or laser product markings created after the final surface treatment.  This practice provides a description of surface characteristics, methods of surface preparation, and methods of marking for metallic surgical implants.

The 3-page ASTM F86-12 replaces the ASTM F86-04(2009) (2004 Edition reaffirmed in 2009) which is now obsolete.   Values are stated in inch-pound units with mathematical conversions to SI units in parentheses (for your information only — not to be considered standard).

All current ASTM standards and many obsolete revisions are available from Document Center Inc. at our website, www.document-center.com.  Many ASTM’s are available in redline editions as well, just ask us about this if you’re interested.  FYI: A listing of all ASTM standards on Surgical Implants will be available on our website when the new updated version is released in early July.  Be sure to check it out!

You may also contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Our staff is available during business hours California time to assist you with all your standards needs and questions.

New ASME B16.11 2011 Edition just released for Forged Fittings, Socket-Welding and Threaded

ASME B16.11, “Forged Fittings, Socket-Welding and Threaded,” has just been released as a new 2011 Edition.  This standard covers ratings, dimensions, tolerances, marking and material requirements for socket-welding and threaded forged fittings.  It’s available from Document Center Inc. now.

These fittings are designated as Class 2000, 3000, and 6000 for threaded end fittings and Class 3000, 6000, and 9000 for socket-weld end fittings.

Customers are sometimes surprised when an edition has one year on the cover but is actually released the following year, as is ASME B16.11.  This just means that the standard was accepted by the association in one year, but actually public distribution was delayed by the publication process until the following year.

ASME B16.11-2011 is intended for manufacturers, owners, employers, users and others concerned with the specification, buying, maintenance, training and safe use of wrought and forged fittings with pressure equipment, plus all potential governing entities.

ASME standards can be purchased from Document Center Inc. via 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 supply both current and obsolete revisions.

BS EN 60601-1 2006 Edition on Medical electrical equipment — General requirements for basic safety and essential performance is now modified by Amendment A11

BS-EN-60601-1, “Medical electrical equipment. General requirements for basic safety and essential performance,” has just been re-released in a new edition and is now available from Document Center Inc.  This British Standard is the UK implementation of EN 60601-1:2006+A11:2011. It is identical to IEC 60601-1:2005.  It supersedes BS EN 60601-1:2006, which is to be withdrawn on October 1st, 2014.

Implementation of CENELEC amendment A11:2011 includes the following: Annex ZZ has been replaced by Annexes ZZA, Coverage of Essential Requirements of EC Directives (93/42/EEC), and ZZB, Coverage of Essential Requirements of EC Directives (90/385/EEC).  The two new Annexes are informative, each providing illumination on how the standard helps to meet the requirements of the directive noted.

Also, BS EN 60601-1:2006+A11:2011 changes the latest date by which any national standards conflicting with this EN standard have to be withdrawn, making the new due date October 1, 2014.

As noted in previous blogs, BS EN 60601-1 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. It is one of our top-sellers here at Document Center and can be ordered on our website, www.document-center.com.  Or order via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here from 6 am to 5 pm Monday through Friday Pacific Time to assist you with all your questions regarding European Standards and Regulations.

 

New BS EN 397 2012 Edition on Industrial Safety Helmets

EN 397, ” Industrial Safety Helmets,” was released in a new revision recently and the official English language edition, BS EN 397:2012, is now available from Document Center Inc.   This European Standard specifies physical and performance requirements, methods of test, and marking requirements for industrial safety helmets.

The mandatory requirements of BS EN 397 apply to helmets for general use in industry in the European Union as mandated by 89/686/EEC for personal protective equipment. Additional optional performance requirements are included to apply only where specifically claimed by the helmet manufacturer.

Industrial safety helmets (also known as headgear) are intended primarily to provide protection to the wearer against falling objects to avoid brain injury and skull fracture.

EN 397:2012 is written by Technical Committee CEN/TC 158 on “Head protection.”  Countries in Europe are expected adopt it as a national standard, either by publication of an identical text or by endorsement, by July 2012, as well as withdrawing conflicting national standards at the same time.

Since EN standards are not published as stand-alone documents, they are available from Document Center  in the many adoptions from the various countries in Europe.  Normally we suggest using the official English language editions, the BS EN documents.  You’ll find them on our website, www.document-center.com.  Please feel free to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) should you have questions or prefer to order off-line.

New EN 1127-1 2011 Edition on Explosive atmospheres – Explosion prevention and protection – Part 1: Basic concepts and methodology affects those certifying to Directive 94/9/EC

BS EN 1127-1 2011 Edition, “Explosive atmospheres – Explosion prevention and protection – Part 1: Basic concepts and methodology,” has just been released.  It is the official English language edition of EN 1127-1:2011.  The administrative process of integrating the new release with the Lists of Harmonized Standards for Directives 94/9/EC and 2006/42/EC is expected to be completed shortly.

EN 1127-1 specifies general design and construction methods to help designers and manufacturers in achieving explosion safety in the design of equipment, protective systems and components at all stages of its use.  It is applicable to any equipment, protective systems and components intended to be used in potentially explosive atmospheres, under atmospheric conditions. These atmospheres can arise from flammable materials processed, used or released by the equipment, protective systems and components or from materials in the vicinity of the equipment, protective systems and components and/or from the materials of construction of the equipment, protective systems and components.

The standard specifies methods for the identification and assessment of hazardous situations leading to explosion and the design and construction measures appropriate for the required safety. This is achieved by risk assessment and risk reduction.

The safety of equipment, protective systems and components can be achieved by eliminating hazards and/or limiting the risk by using a) appropriate design (without using safeguarding); b) safeguarding; c) information for use; d) any other preventive measures.

Measures in accordance with a) (prevention) and b) (protection) against explosions are dealt with in Clause 6, measures according to c) against explosions are dealt with in Clause 7. Measures in accordance with d) are not specified in this European Standard. They are dealt with in EN ISO 12100:2010, Clause 6.

The preventive and protective measures described in EN 1127-1 will not provide the required level of safety unless the equipment, protective systems and components are operated within their intended use and are installed and maintained according to the relevant codes of practice or requirements.

The new BS EN 1127-1:2011 and all BS publications are available from Document Center Inc. through our website, www.document-center.com.  Or if you prefer, you can contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  The various publications for the EN standards can cause confusion.  If you have any questions about what publications you should be using, please contact us.

New Amending Correction has just been released for BS EN 60601-1

BS EN 60601-1:2006, “Medical electrical equipment – General requirements for basic safety and essential performance,” has just been modified by a new Corrigendum 1 correction.  The document is the official English language edition of EN 60601-1.

The corrigendum dated May 31st, 2011, is a consolidated implementation of IEC corrigenda dated in December 2006 and December 2007 (tagged) for the source document IEC 60601-1.   It’s also the  implementation of CENELEC corrigendum March 2010, as well as the  modification of CENELEC Foreword and Annexes ZA and ZZ.

The start and finish of text introduced or altered by IEC corrigendum December 2006 is indicated in the text by one tag. Text altered by IEC corrigendum December 2007 is indicated in the text by another.  There are no clear indications of the location of the modifications to the foreword, the two annexes or the CENELEC Corrigendum.  A review of the previous edition against this one will be necessary.  However, the page count of both the 2006 Edition and this new issue remains constant at 384 pages.

This corrected issue supersedes BS EN 60601-1:1990 and BS EN 60601-1-4:1997 which are declared obsolete and are scheduled for withdrawl on June 1, 2012.  It also supersedes BS EN 60601-1-1:2001 which is withdrawn with the publication of this new revision.

For a copy of the new BS EN 60601-1 or any BS standard, please use 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’re available to assist you with all your standards requirements.

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.

New ASTM D3951 2010 Edition for Commercial Packaging released

ASTM D3951-98, Standard Practice for Commercial Packaging, has been revised with the release of the new 2010 Edition, ASTM D3951-10.  As you can see, this is the first revision of the standard in over 10 years.  It is one of Document Center’s most frequently ordered ASTM standards on packaging and is available now.

ASTM describes the standard as follows:  “(It)  covers the requirements for the commercial preservation, packaging, packing (exterior container), unitization, and marking for supplies and equipment. It provides for multiple handling and shipment by any mode, and storage periods of a minimum of one year in enclosed facilities without damage to the product. It also provides for package quantities suitable for redistribution without additional repackaging or marking. Planned storage that exceeds one year requires more than minimum requirements for physical and mechanical protection.”

You’ll want to know that this practice establishes minimum requirements for packaging of supplies and equipment as covered in Title 49 of the Code of Federal Regulations, with the exclusion of  ammunition, explosives, or hazardous materials.  It is also referenced for some Department of Defense shipments not covered by MIL-STD-2073/1.

Copies of this new ASTM D3951-10 may be purchased in paper or pdf format from Document Center Inc. at www.document-center.com, info@document-center.com, by phone at 650-591-7600 and by fax at 650-591-7617.