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

 

Project

Reference EN 60601-1-9:2008/A1:2013
Title Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
Project Number 24462
Abstract/Scope 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.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2013-11-08
Current Stage code deadline 2014-04-23
Deadline date for vote  

Legal

Directive(s)  
Mandate(s) M/432
Order Voucher  

Details

IEC Technical Body IEC/SC 62A
Reference Document IEC 60601-1-9:2007/A1:2013 (EQV)
ICS 11.040 - Medical equipment
13.020 - Environmental protection
Keywords Medical equipment; Collateral standard; Environment; Design; Conscious
Note 2013-10-02 - BT146_DG9211 extended DOW to 2018-12-31 20130930: Publication allocated to aclausse@cencenelec.eu
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2013-11-08 2014-04-23 export to doc file  EN  FR  DE
5099 2013-07-23 2013-08-20  
5060 2013-05-27 2013-06-17 export to doc file  EN
5020 2013-03-22 2013-05-24  
3090 2013-03-19 2013-03-22  
5060 2013-01-14 2013-02-04 export to doc file  EN
5020 2012-09-28 2013-01-11  
1090 2012-09-25 2012-09-28  

Implementation Dates

date of Ratification (DOR) (1) 2013-07-23
date of Availability (DAV) (2) 2013-11-08
date of Announcement (DOA) (3) 2013-10-23
date of Publication (DOP) (4) 2014-04-23
date of Withdrawal (DOW) (5) 2018-12-31

Relations

Supersedes  
Superseded by  
Normative reference (6)  

(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved


(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat


(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level


(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement


(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn


(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.