ANSI Z87.1 2010 Edition – The standard for eye and face protection in the workplace

When it comes to best selling standards, ANSI Z87.1, “Occupational and Educational Personal Eye and Face Protection Devices,” is near the top of Document Center‘s list.  The reason why?  In the world of personal protective equipment (PPE), it’s the go-to standard for eye and face protection here in the U.S.

This standard provides guidance on general requirements, testing, permanent marking, selection, care, and use of protectors.  The 2010 revision adds specific performance and marking requirements for devices claiming to provide protection from splash/droplet, dust or fine dust hazards that were not included before.

The intent of this document is to minimize the occurrence and severity or prevention of injuries from such hazards as impact, non-ionizing radiation and chemical exposures in occupational and educational environments, as may be found during machinery operations, material welding and cutting, chemical handling, and assembly operations.

ANSI Z87.1-2010 helps users define selection of the appropriate eye and face protective devices based on the hazard.  And to help with compliance, the 2010 edition describes two levels of protection: “Non Impact Rated” and “Impact Rated.”  Further, the standard adopts the European (CE) small and medium head sizes so testing can harmonize with international test methods.

Of course, certain hazardous exposures are not covered in this standard. These include bloodborne pathogens, X-rays, high energy particulate radiation, microwaves, radio-frequency radiation lasers, masers, and sports and recreation.

ANSI standards can be purchased from Document Center Inc. at our webstore, www.document-center.com.  Many are available in both paper and pdf format.  Or you can contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Not only do we accept credit cards, but for U.S. organizations we accept purchase orders conforming to our net 30 terms.  We have been selling standards and providing support services to our customers for 30 years.  We’d like to add you to our list!

New IEC/TR 80001-2 series provides guidance for the Application of risk management for IT-networks incorporating medical devices

IEC has just released 3 new Technical Reports on the application of risk management for IT-networks incorporating medical devices and they’re available now from Document Center Inc. in both paper and pdf format.  The three documents support IEC-80001-1, “Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities.”

IEC/TR 80001-2-1:2012, Application of risk management for IT-networks incorporating medical devices – Part 2-1: Step by step risk management of medical IT-networks – Practical applications and examples

This document is a step-by-step guide to help in the application of risk management when creating or changing a medical IT-network. It provides easy to apply steps, examples, and information helping in the identification and control of risks. All relevant requirements in IEC 80001-1:2010 are addressed and links to other clauses and subclauses of IEC 80001-1 are addressed where appropriate (e.g. handover to release management and monitoring). This technical report focuses on practical risk management. It is not intended to provide a full outline or explanation of all requirements that are satisfactorily covered by IEC 80001-1.

This step-by-step guidance follows a 10-step process that follows subclause 4.4 of IEC 80001-1:2010, which specifically addresses risk analysis, risk evaluation and risk control. These activities are embedded within the full life cycle risk management process. They can never be the first step, as risk management follows the general process model which sets planning before any action.

IEC/TR 80001-2-2:2012, Application of risk management for IT-networks incorporating medical devices – Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

Part 2-1 creates a framework for the disclosure of security-related capabilities and risks necessary for managing the risk in connecting medical devices to IT-networks and for the security dialog that surrounds the IEC 80001-1 risk management of IT-network connection. This security report presents an informative set of common, high-level security-related capabilities useful in understanding the user needs, the type of security controls to be considered and the risks that lead to the controls.

Intended use and local factors determine which exact capabilities will be useful in the dialog about risk. The capability descriptions in this report are intended to supply health delivery organizations (HDOs), medical device manufacturers (MDMs), and IT vendors with a basis for discussing risk and their respective roles and responsibilities toward its management. This discussion among the risk partners serves as the basis for one or more responsibility agreements as specified in IEC 80001-1.

IEC/TR 80001-2-3:2012, Application of risk management for IT-networks incorporating medical devices – Part 2-3: Guidance for wireless networks

This report supports the Healthcare Delivery Organizations (HDO) in the risk management of medical IT-networks that incorporate one or more wireless links. The report, as part of IEC 80001, considers the use of wirelessly networked medical devices on a medical IT-network and offers practical techniques to address the unique risk management requirements of operating wirelessly enabled medical devices in a safe, secure and effective manner. The targeted audience for this technical report is the HDO IT department, biomedical and clinical engineering departments, risk managers, and the people responsible for design and operation of the wireless IT network.

All IEC standards and other documents 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).  You can purchase any standard you need as well as get further information on any standards-related questions you may have.

New ISO/TS 12025 standard issued for Nanomaterials – Quantification of nano-object release from powders by generation of aerosols

ISO has just released a new standard, ISO/TS 12025:2012, “Nanomaterials – Quantification of nano-object release from powders by generation of aerosols,” and it’s available from Document Center Inc. now.

The emissions or release of nano-objects into the surrounding air from powdered nanostructured materials resulting from handling are an important consideration in the design and operation of many industrial processes. Released nano-objects may affect human health and the environment, depending on the nature and quantity of the nanomaterial. It is therefore important to obtain data about the propensity of nanomaterials to release nano-objects, thereby allowing exposure to be evaluated, controlled and minimized.

ISO/TS 12025 provides methodology for the quantification of nano-object release from powders as a result of treatment, ranging from handling to high energy dispersion, by measuring aerosols liberated after a defined aerosolization procedure. In addition to information in terms of mass, the aerosol is characterized for particle concentrations and size distributions.

ISO/TS 12025:2012 provides information on factors to be considered when selecting from the available methods for powder sampling and treatment procedures and specifies minimum requirements for test sample preparation, test protocol development, measuring particle release and reporting data. In order to characterize the full size range of particles generated, the measurement of nano-objects as well as agglomerates and aggregates is recommended in this technical specification.

If you need this standard or any other ISO standard, order on our website, www.document-center.com.  These documents are available in paper or pdf format.  Or contact us for more information by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been in the standards distribution business for 30 years now and can assist you with all your standards needs.

New ANSI/AIHA/ASSE Z9.2 2012 Edition released for Fundamentals Governing the Design and Operation of Local Exhaust Ventilation Systems

The new ANSI/AIHA/ASSE Z9.2, 2012 Edition, has just been released and it’s available from Document Center Inc. in either paper or pdf format.  The new standard, titled “Fundamentals Governing the Design and Operation of Local Exhaust Ventilation Systems,” replaces the now obsolete ANSI/AIHA Z9.2 2006 Edition.

This standard (also known as ANSI Z9.2) establishes minimum requirements for the commissioning, design, specification, construction, and installation of fixed industrial local exhaust ventilation (LEV) systems used for the reduction and prevention of employee exposure to harmful airborne substances in the industrial environment.

Previous revisions of this standard have been incorporated into the OSHA regulations (published in Title 29 of the Code of Federal Regulations).  Additionally, Z9.2 is used not only for design and training, but also for auditing purposes.

Order the standards you need 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’ve been selling standards for 30 years and can assist you with all the services you need to maintain your compliance information.

New AWS D9.1M/D9.1 2012 Edition replaces AWS D9.1 from 2006 for Sheet Metal Welding

AWS has just released the new AWS D9.1M/D9.1, “Sheet Metal Welding Code,” and it’s available now from Document Center Inc.  The new 70-page revision replaces the previous AWS D9.1 2006 Edition, which is now obsolete.

The new 2012 issue has measurement information in both metric and feet and inch format.  It covers arc and braze welding requirements for nonstructural sheet metal fabrications using commonly welded metals available in sheet form up to and including 3 gauge, or 6.4 mm (0.250 in.).

Applications of the code include heating, ventilating, and air conditioning systems, food processing equipment, architectural sheet metal, and other nonstructural sheet metal applications.  Sections include procedure and performance qualification, workmanship, and inspection.

Non-mandatory annexes provide useful information on materials and processes.  AWS D9.1M/D9.1:2012 is not applicable when negative or positive pressure exceeds 30 kPa (5 psi).

All current AWS standards as well as some obsolete editions 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).  Our expert staff is available to assist you with any standards requirements or questions you may have.

New MIL-PRF-85582E released for “Primer Coatings: Epoxy, Waterborne”

There’s a new MIL-PRF-85582 Revision E, “Primer Coatings: Epoxy, Waterborne,” and it’s available now from Document Center Inc.  Changes to the previous MIL-PRF-85582 Revision D are extensive, so unfortunately there’s no margin notations to help you find the updates.

This specification covers the requirements for corrosion inhibiting, chemical and solvent resistant, waterborne, epoxy primer coatings that have a maximum volatile organic compound (VOC) content of 340 grams per liter (g/L) (2.8 pounds per gallon [lb/gal]) as supplied by the manufacturer.

Formerly known as MIL-P-85582, this specification covers two types of coatings:

Type I – Standard pigments
Type II – Low infrared reflective pigments

and three classes:

Class C1 – Barium chromate based corrosion inhibitors
Class C2 – Strontium chromate based corrosion inhibitors
Class N – Non-chromate based corrosion inhibitors

All current Military Specifications and Standards are available from Document Center Inc. in both paper and pdf format at our website, www.document-center.com.  Additionally we have many obsolete revisions as well.  We got our start here in Silicon Valley supporting the defense contracting community and can help you with any standards you currently use in your business.  For more information, contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We happy to be of assistance.

Two new additions to the ISO/IEC 25000 series of standards on Software engineering — Software product Quality Requirements and Evaluation (SQuaRE)

ISO and IEC have just jointly released two new standards in the ISO/IEC 25000 series of standards standards on Software engineering — Software product Quality Requirements and Evaluation (SQuaRE).  The new ISO/IEC 25021:2012 and ISO/IEC 25041:2012 are currently available from Document Center Inc. in either paper or pdf format.

The SQuaRE standards are a result of an effort to harmonize the ISO/IEC 9126 and ISO/IEC 14598 series of standards.  The goal is to assist those developing and acquiring software products with the specification and evaluation of quality requirements. So the 25000 series establishes criteria for the specification of software product quality requirements, their measurement, and evaluation.

ISO/IEC 25021, “Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — Quality measure elements,” provides guides to specify Quality Measure Elements (QME) and an initial set of QME as examples. QME is a measure defined in terms of a property and the measurement method for quantifying it, including the option for transformation by a mathematical function.

ISO/IEC 25021:2012 is intended to be used throughout the system and software product life cycle used with other documents of the ISO/IEC 25000 SQuaRE series, some of which are still at the draft level and not currently available.  The 2012 update is the Second Edition of the standard, replacing the prior First Edition dated 10/15/2007.

ISO/IEC 25041, “Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — Evaluation guide for developers, acquirers and independent evaluators,” provides requirements, recommendations and guidelines for system and software product quality evaluation, for the application of ISO/IEC 25040. The intended audiences of ISO/IEC 25041:2012 are developers, acquirers and independent evaluators of system and software products. The standard is not limited to any specific application area, and can be used for quality evaluation of any type of system and software product.

This new First Edition of ISO/IEC 25041 replaces and revises ISO/IEC 14598-3 and ISO/IEC 14598-4, both of which are now withdrawn.  It also revises ISO/IEC 14598-5, which remains current and in force.

All ISO, IEC and ISO/IEC standards are available from Document Center Inc. in either paper or pdf format 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’re happy to assist you with all your standards requirements — from document purchases to monitoring your standards collection.

New AS 6081, Fraudulent/Counterfeit Electronic Parts: Avoidance, Detection, Mitigation, and Disposition – Distributors Counterfeit Electronic Parts; Avoidance Protocol, Distributors

SAE has just released the new AS 6081, “Fraudulent/Counterfeit Electronic Parts: Avoidance, Detection, Mitigation, and Disposition – Distributors Counterfeit Electronic Parts; Avoidance Protocol, Distributors,” and it’s available now from Document Center Inc. in either paper or pdf format.

This SAE Aerospace Standard standardizes practices to:

  • identify reliable sources to procure parts,
  • assess and mitigate risk of distributing fraudulent/counterfeit parts,
  • control suspect or confirmed fraudulent/counterfeit parts, and
  • report suspect and confirmed fraudulent/counterfeit parts to other potential users and Authority Having Jurisdiction.

Released by SAE’s G-19d Distributor Committee, the new document supports industry efforts to prevent counterfeit parts from infiltrating the Aerospace industry supply chain.

SAE standards can be purchased in either paper or pdf format from Document Center Inc. via 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 been selling standards here in Silicon Valley since 1982 and have the expertise to assist you with your standards questions and requirements.

New Health Informatics Standards released by ISO and available from Document Center Inc.

ISO has just released a number of new Health Informatics Standards and they’re available for purchase now from Document Center Inc. in both pdf and paper format.  Here’s the list for your review:

  • ISO 11238:2012, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances
  • ISO 11239:2012, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

ISO 11239 specifies:

· the structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items related to medicinal products;

· a mechanism for the association of translations of a single concept into different languages;

· a mechanism for the versioning of the concepts in order to track their evolution;

· rules to allow regional authorities to map existing regional terms to the terms created using ISO 11239:2012 in a harmonized and meaningful way.

  • ISO 11240:2012, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement

ISO 11240:

  1. specifies rules for the usage and coded representation of units of measurement for the purpose of exchanging information about quantitative medicinal product characteristics that require units of measurement (e.g. strength) in the human medicine domain;
  2. establishes requirements for units in order to provide traceability to international metrological standards;
  3. provides rules for the standardized and machine-readable documentation of quantitative composition and strength of medicinal products, specifically in the context of medicinal product identification;
  4. defines the requirements for the representation of units of measurement in coded form;
  5. provides structures and rules for mapping between different unit vocabularies and language translations to support the implementation of ISO 11240, taking into account that existing systems, dictionaries and repositories use a variety of terms and codes for the representation of units.

The scope of ISO 11240:2012 is limited to the representation of units of measurement for data interchange between computer applications.

  • ISO 11615:2012, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information

ISO 11615 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of medicinal products.

  • ISO 11616:2012, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

ISO 11616 is intended to provide specific levels of information relevant to the identification of a medicinal product or group of medicinal products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616 is essential to ensuring that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders. This ensures interoperability and compatibility for both the sender and the recipient.

  • ISO 13119:2012, Health informatics — Clinical knowledge resources — Metadata

ISO 13119 specifies a number of metadata elements that describe resources containing medical knowledge. It is primarily applicable to digital documents provided as web resources, accessible from databases or via file transfer, but can be applicable also to paper documents, e.g. articles in medical literature.

Go ahead and purchase your ISO standards on Document Center’s 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).  We’re here to help you Monday through Friday, California business hours.

New AMS 2641 for Hydrocarbon compounds used as a Petroleum Base Vehicle for Magnetic Particle Inspection

SAE has just released the new AMS 2641 Revision B, “Vehicle, Magnetic Particle Inspection, Petroleum Base,” and it’s available now from Document Center Inc. in both paper and pdf format.  The document covers two types of refined liquid hydrocarbon compounds used as a vehicle for the suspension of magnetic particles used in magnetic particle inspection.

AMS 2641B revises section 3.2.3 on Fluorescence and 4.5.1 on Reports.  It was generated as part of the usual five-year review of the standard.  The last revision of the document AMS 2641A released in 1996.

Of course, ASTM E1444/E1444M is probably the major standard on magnetic particle inspection (It replaced AMS 2640).  But SAE has a number of useful standards in this area in addition to the AMS 2641.  Here are some of them:

  • AMS 3040, Magnetic Particles, Nonfluorescent, Dry Method
  • AMS 3041, Magnetic Particles, Nonfluorescent, Wet Method, Oil Vehicle, Ready-to-Use
  • AMS 3042, Magnetic Particles, Nonfluorescent, Wet Method, Dry Powder
  • AMS 3043, Magnetic Particles, Nonfluorescent, Wet Method, Oil Vehicle, Aerosol Packaged
  • AMS 3044, Magnetic Particles, Fluorescent, Wet Method, Dry Powder
  • AMS 3045, Magnetic Particles, Fluorescent, Wet Method, Oil Vehicle Ready-to-Use
  • AMS 3046, Magnetic Particles, Fluorescent, Wet Method, Oil Vehicle, Aerosol Packaged
  • AMS I 83387, Inspection Process, Magnetic Rubber
  • SAE J420, Magnetic Particle Inspection

These magnetic particle inspection standards are all available on 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).  Our staff is available to assist you with your standards needs and questions Monday through Friday, California time.