International Standards and Conformity Assessment for all electrical, electronic and related technologies

SC 62A

Common aspects of electrical equipment used in medical practice

 

Detail

Committee
Working Groups
Project Leader

Current

Status

Frcst Pub

Date

Stability

Date

SC 62AWG 20 F. SchroedePPUB2007-082024

History

Stage
Document
Downloads
Decision Date
Target Date
PNW
62A/451/NP PDF file 269 kB
2004-03-12 
ANW
62A/461/RVN PDF file 219 kB
2004-06-182004-07
1CD
62A/471/CD PDF file 368 kB
2004-10-012005-03
CDM
62A/482/CC PDF file 206 kB
2005-01-21 
A2CD
62A/482A/CC PDF file 157 kB
2005-09-232005-04
2CD
62A/510/CD PDF file 616 kB
2005-09-232005-09
CDM
62A/520/CC PDF file 219 kB
2006-01-132006-02
ACDV
62A/520A/CC PDF file 234 kB
2006-04-212006-03
CCDV
62A/534/CDV PDF file 514 kB
PDF file 532 kB
2006-06-232006-07
AFDIS
62A/563/RVC PDF file 98 kB
2007-01-122007-02
DECFDIS
2007-01-172007-04
RFDIS
2007-01-252007-02
CFDIS
62A/571/FDIS

2007-04-132007-05
APUB
62A/575/RVD PDF file 104 kB
2007-06-192007-08
BPUB
2007-06-202007-07
PPUB
2007-07-102007-09
 2019-06

Abstract

IEC 60601-1-9:2007 The objective of this collateral standard is to improve the environmental impact for the entire range of medical electrical equipment, taking into account all stages of the product life cycle:
- product specification;
- design;
- manufacturing;
- sales, logistics, installation;
- use;
- end of life management. This means protecting the environment and human health from hazardous substances, conserving raw materials and energy, minimizing the generation of waste, as well as minimizing the adverse environmental impacts associated with waste. The criteria needed to reach this goal must be integrated into all stages of the medical electrical equipment life cycle from the specification stage to end of life management. The environmental impacts of me equipment through all life-cycle stages are determined from the medical electrical equipment's environmental aspects defined during the identification of need, product planning, and design stages. Consideration of environmental aspects as early as possible in these stages can produce numerous benefits that might include lower costs, stimulation of innovation and creativity, and increased knowledge about the product. It can also provide new business opportunities, and improved product quality as well as reduction of adverse environmental impacts. The assessment of the environmental aspects and impacts of medical electrical equipment is a developing science and it is anticipated that this collateral standard will require periodic updating as the science develops. The requirements given in this collateral standard do not replace national or international laws and regulations. Environmental protection is one element of the overall risk management process as required by the general standard. The acceptability of medical electrical equipment's environmental impacts are balanced against other factors, such as the product's intended function, performance, safety, cost, marketability, quality, legal and regulatory requirements. This balance can differ depending on the intended function of the medical electrical equipment. For example, a solution appropriate for life-saving or life-supporting medical electrical equipment might not be appropriate for a device intended to correct a minor ailment. A manufacturer of medical electrical equipment might have to justify, as a result of risk management, that a medical benefit outweighs the associated adverse environmental impacts.

Project

IEC 60601-1-9:2007 ED1

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

 

 

Associated Documents:

62A/980/RM

PDF file 306 kB
62A/965/INF

PDF file 148 kB
62A/701/RR

PDF file 48 kB
62A/1322/RR

PDF file 110 kB