CENELEC
Project
| Reference | EN 60601-1-9:2008 |
|---|---|
| Title | Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
| Project Number | 20739 |
| 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 | 2008-04-29 |
| Current Stage code deadline | 2009-02-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD pending (93/42/EEC) |
|---|---|
| Mandate(s) | |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62A |
|---|---|
| Reference Document | IEC 60601-1-9:2007 (EQV) |
| ICS | 11.040 - Medical equipment 13.020 - Environmental protection |
| Keywords | Medical equipment; Collateral standard; Environment; Design; Conscious |
| Note | |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
|
Product Life Cycle
|
Information
|
|---|---|---|---|
| All | Others | Raw Material, Manufacturing, Use, Recovery, Disposal | B2B, B2C, DfE |
History
Implementation Dates
| date of Ratification (DOR) (1) | 2008-04-16 |
|---|---|
| date of Availability (DAV) (2) | 2008-04-29 |
| date of Announcement (DOA) (3) | 2008-08-01 |
| date of Publication (DOP) (4) | 2009-02-01 |
| date of Withdrawal (DOW) (5) | 2011-05-01 |
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.
