Information

Medical Standards List with Publish Dates

MECA IEC 60601 ISO 80601 Medical Standards List (Rev 2018-11-17c)

• (Note, this document was revised on the specified date, so may not be current)
• Harmonized Standards with Publish Dates (Collaterals, Particulars)
• Anticipated publish dates for new standards, editions, amendments
• To find the current status and issue dates of these standards, see the Links Page, Standards
• To find and download full standards (which are copyrighted), please see the Resources page, Purchasing Standards

MECA 60601-1 Ed. 3.1 Evaluation Package (BETA)

MECA 60601-1 Ed3.1 Evaluation Package BETA (2018-11-24).pdf

• The Evaluation Package is a summary of the IEC 60601-1:2012 standard, other applicable requirements, guidance information, and interpretations, to help evaluate medical electrical equipment to the requirements of the Standard.
• It is being provided FREE of charge, to help people understand and meet the requirements for medical devices.
• The Evaluation Package is not intended to replace the standard, so a purchased copy should also be used.
• NOTE – This document is still under development, and only pages 1-37 are being provided at this time.
• It will be updated here as it is completed.

Risk Management Guidance Form for ISO 14971

ISO 14971 MECA F 027b – ISO 14971 Client Completion Form (0.2Revision)

• Covers Clause 4.2.2 of IEC 60601-1, Ed. 3.1, which is ISO 14971, Clauses 3.1 – 8
• Clients who have an evaluation project with MECA receive this in an editable Word format to complete

Risk Management Guidance Form for IEC 60601-1

IEC 60601-1 MECA F 028c – IEC 60601-1 2012 Risk Management Client Completion Form (0.2Revision)

• Covers Risk Management referenced Clauses in IEC 60601-1, Ed. 3.1
• Clients who have an evaluation project with MECA receive this in an editable Word format to complete

IEC 60601-1, Edition 3.1 Label-Manual Checklist

MECA IEC 60601-1 Ed3.1 Label-Manual Checklist Rev4.pdf (2015-01-28)

• Checklist for the requirements of the Labelling and Accompanying documents

Medical Alarm Standards Cross-Reference

meca-alarm-standards-cross-reference20150401.pdf (2015-04-01)

• A comparative resource for those who work with alarm systems and the corresponding standards in the field of medical electrical equipment.
• Note, IEC authorization has been received to publish wording from these standards.

Medical Standards Project Scope Tool

MECA 60601-80601 Medical Standards Project Scope Tool (Rev 2015-08-17).pdf (2015-08-17)

• A list of IEC 60601 and the IEC/ISO 80601 Collateral and Particular standards, with their referenced and required additional standards and requirements.
• This is a great tool to be sure you’ve included everything when determining the applicable standards and requirements.

IEC 60601-1 Critical Components Guidance Documents

Critical Components Guidance Table (Rev35).doc

• Critical Component Guide for IEC 60601-1
• This guidance document will aid you in identifying your device’s critical components and what specifications they may need to meet for documentation in your Compliance Report.

MECA 60601-1 Ed. 2 with National Differences Evaluation Package

MECA-60601Eval-Rev35.pdf

• The Evaluation package is a summary of the IEC 60601-1:1988 + A1:1991 + A2:1995 standard, project process, national differences, and guidance information to help evaluate medical electrical equipment to the requirements of the Standard.
• It is being provided FREE of charge, to help people understand and meet the requirements for medical devices.
• The Evaluation Package is not intended to replace the standard, so a purchased copy should also be used.

Get a quote, call: 262.752.4017

To receive a complete quote, please submit an online request or call us.