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GOOD HOSPITAL PRACTICE

GOOD HOSPITAL PRACTICE

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QM according to DIN EN 15224 / ISO 9001

3.6.36 Central sterilisation

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Identification

If sterilisation is carried out for third parties, the sterilisation department is a medical device manufacturer and must comply with the DIN EN ISO 13485:2009 standard. The standard should also be complied with for internal operations.

Name of the service

Organisation chart

Management

Contact persons

General task

Who are the customers?

Service catalogue

Quality policy

Contractual agreements

Communication

Editing the interface

Usual procedure within the service

Delivery times/response times

Report form

Complaints option

References

Notes and comments

Applicable documents

Guidelines of the German Society for Hospital Hygiene (DGKH)
Requirements for the qualification of the persons carrying out the work (DGSV)
Hygiene requirements for the reprocessing of medical devices of the KRINKO at the RKI
There are also further standards and guidelines

SPECTARIS German Industry Association for Optical, Medical and Mechatronic Technologies e.V. Recommendations for process validation

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3.6.36 Central sterilisation

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