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IEC 60601-1-9:2007

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

Edition date: 2007-07-10
In Force
Available languages: Spanish, English, French
Summary: 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.

La CEI 60601-1-9:2007 L'objectif de la présente norme collatérale est d'améliorer l'impact environnemental pour toute la gamme d'appareils électromédicaux en tenant compte de toutes les étapes du cycle de vie du produit:
- spécification du produit;
- conception;
- fabrication;
- ventes, logistique, installation;
- utilisation;
- gestion de la fin de vie. Cela signifie protéger l'environnement et la santé des personnes contre les substances dangereuses, économiser les matières premières et l'énergie, minimiser la production de déchets, ainsi que minimiser les impacts environnementaux négatifs associés aux déchets. Les critères nécessaires pour atteindre ce but doivent être intégrés dans toutes les étapes du cycle de vie des appareils électromédicaux, dès l'étape de spécifications jusqu'à la gestion de fin de vie. Les impacts environnementaux des appareils électromédicaux à travers toutes les étapes du cycle de vie sont déterminés à partir des aspects environnementaux des appareils électromédicaux définis pendant les étapes d'identification des besoins, de planification et de conception du produit. La prise en compte des aspects environnementaux le plus tôt possible pendant ces étapes peut apporter de nombreux bénéfices qui pourraient inclure des coûts réduits, une stimulation de l'innovation et de la créativité et une meilleure connaissance du produit. Elle peut aussi apporter des nouvelles opportunités d'affaires, une meilleure qualité du produit ainsi qu'une réduction des impacts environnementaux négatifs. L'analyse des aspects et impacts environnementaux des appareils électromédicaux est une science en cours de développement et il est prévu que cette norme collatérale exige une mise à jour périodique au fur et à mesure que la science se développe. Les exigences données dans la présente norme collatérale ne remplacent pas les lois et réglementations nationales ou internationales. La protection environnementale est un des éléments du processus de gestion des risques global tel que demandé par la norme générale. L'acceptabilité des impacts environnementaux des appareils électromédicaux est prise en compte par rapport à d'autres facteurs, tels que la fonction prévue du produit, sa performance, sa sécurité, son prix, sa facilité de mise sur le marché, sa qualité, les exigences légales et réglementaires. L'équilibre peut être différent et dépend de la fonction prévue de l'appareil électromédical. Par exemple, une solution appropriée pour les appareils électromédicaux de sauvetage ou de maintien de la vie peut ne pas être appropriée pour un dispositif destiné à corriger une maladie mineure. Un fabricant d'appareils électromédicaux pourrait être amené à justifier, comme résultat de la gestion des risques, qu'un bénéfice médical à un poids plus important que les impacts environnementaux négatifs associés.
ICS: 11.040.01-Medical equipment in general, 13.020.01-Environment and environmental protection in general
CTN: TC 62/SC 62A - 1359

Modificaciones Normas

Es modificada por IEC 60601-1-9:2007/AMD1:2013

Es modificada por IEC 60601-1-9:2007/AMD2:2020

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