Sterilisering

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 11 dec 2018
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This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizer for medical devices. However, specific loads (e. g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.

Large steam sterilizers can also be used during the commercial production of medical devices.

This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process pathogenic substances or human tissues.

This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.

This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.

NOTE Attention is drawn to the standards for quality management systems e. g. EN ISO 13485.

Planning and design of sterilizers applying to this European Standard should consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex A.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 17 dec 2018
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This International Standard specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled ‘sterile’ and to CBHPs not labelled ‘sterile’.

This International Standard is not applicable to:

— procurement and transport of cell-based starting material used in processing of a CBHP,

— cell banking,

— control of genetic material,

— control of non-microbial product contamination,

in vitro diagnostics (IVDs), or

— natural medicines.

EXAMPLE Vitamins and minerals, herbal remedies, homoeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, other products such as amino acids and essential fatty acids.

This International Standard does not define biosafety containment requirements.

This International Standard does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.