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Specifications
Compliance
102
Item
Quality System
EN ISO 13485: 2000,
ISO 13485: 1996
EC Directive
93/42/EEC
FDA Guidance
FDA RG (Nov. 1993)
Safety — EC
EN 60601-1: 1995
Safety — USA
UL 60601-1: 2003
Safety — Canada
CSA C22.2 No 601,
1-M90: 1998
Electric Shock
EN 60601-1
Classification
Protection against
EN 60601-1
Water Classification
Mode of Operation
EN 60601-1
Classification
Flammable
EN 60601-1
Anaesthetic
Classification
Safety
ISO 9919: 2005(E)
EMC
EN 60601-1-2
Standard
Quality system — Medical
Devices, Particular
Requirements for application
of ISO 9001: 2000
Medical Device Directive
(Europe + Int.)
Reviewers Guide for
Premarket Notification
Submission
General Rqmts for Safety,
Medical Equipment
Safety — Medical Electrical
System
Safety — Medical Electrical
Sys, Requires NRTL Listing
Class I or Internally powered
(Battery mode), Type BF
Applied part
IPX1
Continuous Operation
Equipment not suitable
Particular requirements for the
basic safety and essential
performance of pulse oximeter
equipment for medical use.
Medical Electric Equipment,
Collateral Standard: EMC-
Requirements and Test, 2nd
Edition, 2001
Description
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