| Publication CODE |
Title |
| IEC 60601-1-9:2007+AMD1:2013 CSV (2013-06) |
MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FORBASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
276.00 €
|
61 P. |
Description
IEC 60601-1-9:2007+A1:2013 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.
This consolidated version consists of the first edition (2007)
and its amendment 1 (2013). Therefore, no need to order amendment in
addition to this publication.
|
| Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
|
| Status |
IEC PUBLICATION |
| Situation |
Currently active
|
|
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
| BEC Approval |
2013-06-18 |
| ICS-Code (International Standards Classification) |
11.040.01
, 13.020.01
|
| NBN Status |
New |
|
| IEC publication date |
2013-06-18 |
| IEC stability date |
2024-12-31 |
| IEC last modification date |
2020-07-22 |
|
