IEC 60601-1:2005/ISH1:2008
(Main)Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Feuille d'interprétation 1 - Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles
General Information
- Status
- Published
- Publication Date
- 24-Apr-2008
- Technical Committee
- SC 62A - Common aspects of medical equipment, software, and systems
- Current Stage
- PPUB - Publication issued
- Start Date
- 25-Apr-2008
- Completion Date
- 30-Jun-2008
Relations
- Effective Date
- 05-Sep-2023
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
IEC 60601-1:2005/ISH1:2008 is a standard published by the International Electrotechnical Commission (IEC). Its full title is "Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". This standard covers: Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1:2005/ISH1:2008 is classified under the following ICS (International Classification for Standards) categories: 11.040.01 - Medical equipment in general. The ICS classification helps identify the subject area and facilitates finding related standards.
IEC 60601-1:2005/ISH1:2008 has the following relationships with other standards: It is inter standard links to IEC 60601-1:2005. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
IEC 60601-1:2005/ISH1:2008 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
Publication IEC 60601-1 (Third edition – 2005) I-SH 01
MEDICAL ELECTRICAL EQUIPMENT –
Part 1: General requirements for basic safety
and essential performance
INTERPRETATION SHEET 1
This interpretation sheet has been prepared by SC 62A: Common aspects of electrical
equipment used in medical practice
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/599/ISH 62A/613/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 1.1
This subclause is clarified by the following:
IEC 60601-1 does not apply to medical gas pipeline systems covered by ISO 7396-1, Medical
gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum.
NOTE Subclause 6.3 of ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and alarm
signals.
This clarification will remain valid until a new version of IEC 60601-1 is published.
___________
April 2008
Publication CEI 60601-1 (Troisième édition – 2005) I-SH 01
A
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...