This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.<\/p>\n
This includes information for processing prior to use or reuse of the medical device.<\/p>\n
Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:<\/p>\n
initial treatment at the point of use;<\/p>\n<\/li>\n
preparation before cleaning;<\/p>\n<\/li>\n
cleaning;<\/p>\n<\/li>\n
disinfection;<\/p>\n<\/li>\n
drying;<\/p>\n<\/li>\n
inspection and maintenance;<\/p>\n<\/li>\n
packaging;<\/p>\n<\/li>\n
sterilization;<\/p>\n<\/li>\n
storage;<\/p>\n<\/li>\n
transportation.<\/p>\n<\/li>\n<\/ol>\n
This document excludes processing of the following:<\/p>\n
non-critical medical devices unless they are intended to be sterilized;<\/p>\n<\/li>\n
textile devices used in patient draping systems or surgical clothing;<\/p>\n<\/li>\n
medical devices specified by the manufacturer for single use only and supplied ready for use.<\/p>\n<\/li>\n<\/ul>\n
See ISO 17664-2:2021<\/span>, Annex E<\/span>, for further guidance on the application of the ISO 17664 series<\/span><\/span> to a medical device.<\/p>\n<\/div>\n Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices – Critical and semi-critical medical devices<\/b><\/p>\nPDF Catalog<\/h4>\n
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\n PDF Pages<\/th>\n PDF Title<\/th>\n<\/tr>\n \n 2<\/td>\n National foreword <\/td>\n<\/tr>\n \n 6<\/td>\n European foreword <\/td>\n<\/tr>\n \n 8<\/td>\n Annex ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/745 aimed to be covered <\/td>\n<\/tr>\n \n 10<\/td>\n Foreword <\/td>\n<\/tr>\n \n 11<\/td>\n Introduction <\/td>\n<\/tr>\n \n 13<\/td>\n 1 Scope <\/td>\n<\/tr>\n \n 14<\/td>\n 2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n\n 17<\/td>\n 4 Validation of the processes identified in the information provided by the medical device manufacturer
5 Risk analysis <\/td>\n<\/tr>\n\n 18<\/td>\n 6 Information to be provided by the medical device manufacturer
6.1 General
6.2 Processing instructions <\/td>\n<\/tr>\n\n 19<\/td>\n 6.3 Limitations and restrictions on processing
6.4 Initial treatment at the point of use
6.5 Preparation before cleaning <\/td>\n<\/tr>\n\n 20<\/td>\n 6.6 Cleaning
6.6.1 General
6.6.2 Automated cleaning
6.6.3 Manual cleaning <\/td>\n<\/tr>\n\n 21<\/td>\n 6.7 Disinfection
6.7.1 General
6.7.2 Automated disinfection <\/td>\n<\/tr>\n\n 22<\/td>\n 6.7.3 Manual disinfection
6.8 Drying
6.9 Inspection and maintenance <\/td>\n<\/tr>\n\n 23<\/td>\n 6.10 Packaging
6.11 Sterilization <\/td>\n<\/tr>\n\n 24<\/td>\n 6.12 Storage
6.13 Transportation
7 Presentation of the information <\/td>\n<\/tr>\n\n 25<\/td>\n Annex A (informative) Commonly utilized processing methods <\/td>\n<\/tr>\n \n 29<\/td>\n Annex B (informative) Example of processing instructions for reusable medical devices <\/td>\n<\/tr>\n \n 31<\/td>\n Annex C (informative) Classification of medical devices <\/td>\n<\/tr>\n \n 34<\/td>\n Annex D (informative) Additional guidance on information to be provided by the medical device manufacturer <\/td>\n<\/tr>\n \n 35<\/td>\n Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" \n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n BSI<\/b><\/a><\/td>\n 2021<\/td>\n 36<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":381703,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-381696","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/381696","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/381703"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=381696"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=381696"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=381696"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}