Table of Contents
Advertisement
Compliance
N-550B
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
EN 60601-1
Operation
Classification
Flammable
EN 60601-1
Anaesthetic
Classification
EMC
EN 60601-1-2
EMC
EN 55011, Class B/
Group 1
Safety Alarms
EN 475: 1995
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 1 or Internally powered
(Battery mode), Type BF Applied
part
IPX1
Continuous Operation
Equipment not suitable
Medical Electric Equipment,
Collateral Standard: EMC-
Requirements and Test, 2nd
Edition, 2001
EMC Disturbance Characteristics
— Limits and Methods of
Measurement, Industrial Scientific
and Medical (ISM) RF
Equipment, Edition 3.1,1999-08
Alarm Rqmts — Medical
Equipment
Specifications
Description
85
Advertisement
Table of Contents
