Category: Top 10 Standards on… Series

The Top 10 Standards for Various Areas of Interest

The ISO 10993 Series on Biological evaluation of medical devices

The ISO-10993 Series on Biological Evaluation of Medical Devices is an essential part of every Medical Device company’s standards collection.  They are among Document Center’s all-time best selling Medical Device Standards.

The ISO-10993 Parts cover a broad range of principles and tests for the biological evaluation of medical devices within a risk management process.  Medical devices are categorized by the nature and duration of the contact of the device with the body.  The series helps the user identify and evaluate existing relevant data, identify gaps using risk analysis, identify where further information is necessary, and provides guidance on needed testing.  It is a must-have series for medical device manufacturers, researchers, laboratories, and regulators.

New releases in this  series (dated in 2010) are the Corrigendum 1 (Correction Sheet) for the ISO-10993-1, the ISO-10993-10:2010, the ISO-10993-13:2010, and the ISO-10993-16:2010.

Here’s the complete list of 10993 Standards.

  • ISO 10993-1 – Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
  • ISO 10993-2 – Biological evaluation of medical devices Part 2: Animal welfare requirements
  • ISO 10993-3 – Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-4 and Amd 1 – Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
  • ISO 10993-5 – Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-6 – Biological evaluation of medical devices Part 6: Tests for local effects after implantation
  • ISO 10993-7 – Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
  • ISO 10993-8 – Withdrawn – Biological evaluation of medical devices Part 8: Selection and qualification of reference materials for biological tests
  • ISO 10993-9 – Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
  • ISO 10993-10 – Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
  • ISO 10993-11 – Biological evaluation of medical devices Part 11: Tests for systemic toxicity
  • ISO 10993-12 – Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)
  • ISO 10993-13 – Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
  • ISO 10993-14 – Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
  • ISO 10993-15 – Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
  • ISO 10993-16 – Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
  • ISO 10993-17 – Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
  • ISO 10993-18 – Biological evaluation of medical devices Part 18: Chemical characterization of materials
  • ISO/TS 10993-19 – Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
  • ISO/TS 10993-20 – Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices

The complete set can be purchased as a package as well (ISO-10993-Package).  Contact Document Center Inc. at 650-591-7600 or on our website at www.document-center.com.

The Plating Spec Poster – A handy tool for plating and coating specialists

Techplate’s Plating and Anodizing Specifications Chart is a handy wall chart developed to summarize a variety of frequently referenced plating specs.

The 2006 Edition covers a wide variety of metals and coatings.  Various classes are covered, along with thicknesses, and applications.  It’s 18 inches wide by 24 inches high, so it’s easy to post and reference.

Here is a list of some of the coatings covered and specs that apply:

Anodic Coatings MIL-A-8625
Black Chromium Plating MIL-DTL-14538
Black Oxide Coating MIL-DTL-13924 and AMS-2485
Cadmium Plating AMS-2700 and ASTM-B766
Chemical Conversion Coatings MIL-DTL-5541
Chromium Plating AMS-2460
Chemical Finish Black MIL-F-495
Copper AMS-2418
Electroless Nickel Coatings AMS-2404 and AMS-C-26074
Electropolish ASTM-B912
Gold Plating ASTM-B488 and AMS-2422
Lubricant, Solid Film MIL-PRF-46010
Magnesium Anodic Treatment AMS-M-45202 and ASTM-D1732
Magnesium Chromic Treatment AMS-M-3171
Nickel Coatings AMS-QQ-N-290 and AMS-2403
Passivation Treatments AMS-2700
Light Phosphate Coating TT-C-490
Heavy Phosphate Coating MIL-DTL-16232
Salt Bath Nitride AMS-2753
Silver Plating ASTM-B700
Sulfamate Nickel MIL-P-27418
Tin Coatings ASTM-B545
Tin Lead Plating AMS-P-81728
Vacuum Cadmium Plating AMS-C-8837
Zinc ASTM-B633
Zinc Alloy Plating ASTM-B840 and ASTM-B841

The ISO 9000 Compendium – The top quality standards at a low price

The ISO-9000 Compendium 12th Edition is a real bargain in the world of standards.  You get a real cross-section of the important quality standards at a reasonable price.  Yes, it is only available in CD Rom format (Now in pdf format as well.)  But you will be able to review many more documents than you could otherwise.

Of course, there is one major problem with ordering any compilation of standards.  The documents may be revised individually while the compilation stays static.  This is certainly the case with the current issue of the ISO 9000 Compendium.  The final draft for the ISO-9004 has been approved and is now available as an authorized edition, rather than the draft included in the compendium.

So, if you need to be sure you’re meeting the ISO-9001 certification requirements but want to take a look at the balance of the collection just for informational purposes only, you may want to purchase the compendium.  Then, get notification service for the ISO-9001 document.  That way, you’ll find out right away when any changes are made to the document you use for certification.

Here’s the contents of the current  Twelveth Edition  (along with links to the current edition of each item as a solo purchase):

  • ISO 9000 : 2005 Quality management systems — Fundamentals and vocabulary
  • ISO 9001 : 2008 Quality management systems — Requirements (With Technical Corrigendum)
  • ISO 9004 : 2000 Quality management systems — Guidelines for performance improvements
  • ISO 10001 : 2007 Quality management systems — Customer Satisfaction — Guidelines for codes of conduct for organizations
  • ISO 10002 : 2004 Quality management systems — Customer Satisfaction — Guidelines for complaints handling in organizations
  • ISO 10003: 2007 Quality management systems — Customer Satisfaction — Guidelines for dispute resolution external to organizations
  • ISO 10005 : 2005 Quality management systems — Guidelines for quality plan
  • ISO 10006 : 2003 Quality management — Guidelines for quality management in projects
  • ISO 10007 : 2003 Quality management systems — Guidelines for configuration management
  • ISO 10012 : 2003 Measurement management systems — Requirements for measurement processes and measuring equipment
  • ISO/TR 10013 : 2001 Guidelines for quality management system documentation
  • ISO 10014 : 2006 Quality management — Guidelines for realizing financial and economic benefits (With Technical Corrigendum)
  • ISO 10015 : 1999 Quality management — Guidelines for training
  • ISO/TR 10017 : 2003 Guidance on statistical techniques for ISO 9001:2000
  • ISO 10019 : 2005 Guidelines for the selection of quality management system consultants and use of their services
  • ISO 19011 : 2002 Guidelines for quality and/or environmental management systems auditing
  • ISO/DIS 9004 Managing for the sustained success of an organization — A quality management approach

Our Top 10 Health Information Technology Standards — and 4 you must know about…

Having trouble knowing where to start with your Electronic Medical Record implementation?  Here’s our list of some of the most important Health Information Technology Standards to help you get familiar with the field.

1.  ASTM-E2553 – Guide for Implementation of a Voluntary Universal Healthcare Identification System

This guide provides you with implementation principles needed to create a healthcare identification system.  It is intended to help you clearly identify the individuals in your healthcare delivery system.

2.  ASTM-E1714 – Guide for Properties of a Universal Healthcare Identifier (UHID)

Originally intended for the U.S. population, the guide covers a set of requirements “outlining the properties required to create a universal healthcare identifier system.”   The goal:

Positive identification of patients, automatic links to all computer-bases records on that patient, data security, and record handling efficiency.

3.  ISO-27799 – Health informatics — Information security management in health using ISO/IEC 27002

The standard provides you with a set of detailed controls and security best practices.  It will assist in the implementation of a system that maintains confidentiality, integrity of information, and availability of patient health records.  It covers a wide variety of data formats.

4.  ISO-21548 – Health informatics — Security requirements for archiving of electronic health records – Guidelines

A companion to the document below, this is an implementation guide for EMR archiving.

 

5.  ISO-21547 – Health informatics — Security requirements for archiving of electronic health records — Principles

This technical specification defines the basic principles required to preserving health records in any format.  It is focused on document and records management, with an emphasis on privacy protection.

6.  ISO-22600-1 – Health informatics — Privilege management and access control — Part 1: Overview and policy management

Another technical specification, this time supporting the needs of record sharing partners as diverse as health insurance companies, patients, government, and other healthcare organizations.

7. ASTM-E1869 – Guide for Confidentiality, Privacy, Access, and Data Security Principles for Health Information Including Electronic Health Records

This standard is another take on the issues of patient privacy and confidentiality. It provides the user with basic principles and ethical practices for handling confidential patient information.

8. ASTM-E1985 – Guide for User Authentication and Authorization

This guide can assist healthcare providers who are implementing EMR software by providing information on the design, implementation and use of authentication mechanisms.

9.  ISO-18308 – Health informatics — Requirements for an electronic health record architecture

This technical specification assembles a set of clinical and technical requirements for EMR architecture.  It’s goal is to support the exchange of health records across various sectors and jurisdictions.

10.  ASTM-E1384 – Practice for Content and Structure of the Electronic Health Record (EHR)

This is the ASTM take on what the content and logical data structure of an EMR needs to be.  It provides a common vocabulary to assist in the development, purchase and implementation of EMR systems.  It helps map the content of the EMR to a number of biomedical and other health informatics standards.

And the 4 Standards you need to know about:

HL7-CDA – The Clinical Document Architecture

This standard provides an XML-based model for the exchange of clinical documents (like discharge summaries).  The document creates information that is both machine- and human-readable.  Display is available in web-browsers and wireless applications like cell phones.  It tends to be used in applications for large-scale implementation, like large hospital chains.

CCD – Continuity of Care Document

This is a joint standard generated by ASTM and HL7 to combine the benefits of the ASTM CCR standard (below) and the HL7 CDA standards (above).  It is for use in the U.S. only.  It basically is a method to create simpler documents now (probably from legacy information) with a migration path to the more complex CDA protocol later.

ASTM-E2369 – Specification for Continuity of Care Record (CCR)

This standard also provides for the exchange of clinical documents, with some XML, in a more flexible schema.  The goal in creating the standard was to tag specific elements in a health record so that data could be communicated in a vendor-neutral fashion.  It tends to be used in smaller-venue applications.

DICOM – Digital Imaging and Communications in Medicine

DICOM is a multi-part document created by a joint committee of the American College of Radiology and the National Electrical Manufacturers Association.  It defines standard methods of transmission of medical images and their associated information.  The importance of DICOM in the Health Informatics is that it addresses the integration of specialty application information into the Electronic Health Record.

A complete list of Health Informatics Standards is available at our website:

www.document-center.com

Please contact me, Claudia Bach, with any questions you might have.