Standards

IEC/ISO/EN Standards

Current IEC, ISO, and EN Standards List, With Dates

Purchasing Standards

NOTE: Standards are copyrighted and not available in their published form for free.

We suggest searching each source below for the best price on the standards you need.

IEC Web Store – Purchase IEC standards
AAMI – Purchase AAMI standards
UL Standards Sale Site – UL standards Store
TechStreet – Purchase IEC, ISO, UL, AAMI, CSA, EN, etc. standards
IHS Engineering – Purchase IEC, ISO, UL, AAMI, CSA, EN, etc. standards

Test Equipment For Medical Devices

The following is test equipment that we use in our lab, and we have found to work exceptionally well.

Whale Teq

Test and measurement equipment for medical equipment, primarily ECG and Electrosurgical Test and verification. We use this test equipment in our lab for testing medical equipment for internationally accredited reports. There is nothing we’ve found on the market that does what these ECG and Electrosurgical testers do.

Associates

The following is an associate that we have a long experience working with, and recommend for their high quality services.

MethodSense, Inc.

Risk assessment and Risk Management solutions/.consulting for Life Science Companies. Expertise includes IEC 60601-1, ISO 14971, ISO 13485, MDD 93/42/EEC, 21 CFR Part 820, AS/NZS ISO 31000, Annex 11, 21 CFR Part 11, and other regulations and standards. Expertise also includes FDA submission support, quality assurance management system development, medical device technology and software compliance, software validation, and business operations efficiency strategies for life science companies.

Contact: Russ King at rking@methodsense.com

MECA Free Downloads

To aid in design and development, MECA provides free downloads with tools to evaluate medical electrical equipment to the applicable standards.

Free Downloads
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