Source: https://infostore.saiglobal.com/en-us/Standards/ISO-80601-2-56-2017-596955_SAIG_ISO_ISO_1367437/
Timestamp: 2020-01-23 13:57:41
Document Index: 160063426

Matched Legal Cases: ['ART 2', 'ART 2', 'ART 2', 'ART 1', 'ART 2', 'ART 1', 'ART 1', 'ART 5']

ISO 80601-2-56 : 2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERA | SAI Global
ISO 80601-2-56 : 2017
201.6 Classification of ME EQUIPMENT and ME
201.7 ME EQUIPMENT identification, marking and
201.101 Laboratory performance requirements
201.102 CLINICAL ACCURACY VALIDATION
201.103 PROBES, PROBE CABLE EXTENDERS
and PROBE COVERS
202 Electromagnetic disturbances - Requirements and tests
211 Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare
212 Requirements for medical electrical equipment and
medical electrical systems intended for use in the
emergency medical services environment
requirements for ME EQUIPMENT and
Annex BB (informative) - Reference temperature source
Annex CC (informative) - Reference to the essential
principles of safety and performance
of medical devices in accordance with
Annex DD (informative) - Terminology - Alphabetized
This document applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. .
ProductNote This standard also refers:- IEC 62366-1:2015
ISO/DIS 80601-2-56 : 60.00 (2017)
ISO 80601-2-56 : 2009
NF EN ISO 80601-2-56 : 2017 Identical
DIN EN ISO 80601-2-56 : 2018 Identical
DIN EN ISO 80601-2-56 : 2013 Identical
PN EN ISO 80601-2-56 : 2017 Identical
I.S. EN ISO 80601-2-56:2017 Identical
ONORM EN ISO 80601-2-56 : 2018 Identical
NEN EN ISO 80601-2-56 : 2017 Identical
SS-EN ISO 80601-2-56:2017 Identical
UNI EN ISO 80601-2-56 : 2017 Identical
UNE-EN ISO 80601-2-56:2018 Identical
BS EN ISO 80601-2-56 : 2017 Identical
DS EN ISO 80601-2-56 : 2017 Identical
EN ISO 80601-2-56 : 2017 Identical
NS EN ISO 80601-2-56 : 2017 Identical
SN EN ISO 80601-2-56 : 2017 Identical
DIN EN ISO 80601-2-56 E : 2013 Identical
UNI EN ISO 80601-2-56 : 2013 Identical
SANS 80601-2-56 : 1ED 2010 Identical
UNE EN ISO 80601-2-56 : 2013 Identical
NBR ISO 80601-2-56 : 2013 Identical
NBN EN ISO 80601-2-56 : 2012 Identical
BS EN 60601-2-20 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS
I.S. EN 60601-2-19:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS
EN 62366-1 : 2015 COR 2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015)
IEC 60601-2-19 : 2.1 MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS
EN 60601-1-12 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT (IEC 60601-1-12:2014)
EN 60601-1:2006/A12:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005)
EN 12470-5 : 2003 CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE)
Health care technology Medical equipment Diagnostic equipment