{"id":279306,"date":"2024-10-19T18:50:35","date_gmt":"2024-10-19T18:50:35","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-15883-72016\/"},"modified":"2024-10-25T15:24:34","modified_gmt":"2024-10-25T15:24:34","slug":"bs-en-iso-15883-72016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-15883-72016\/","title":{"rendered":"BS EN ISO 15883-7:2016"},"content":{"rendered":"
This part of ISO 15883 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following:<\/p>\n
bedframes;<\/p>\n<\/li>\n
bedside tables;<\/p>\n<\/li>\n
transport carts;<\/p>\n<\/li>\n
containers;<\/p>\n<\/li>\n
surgical tables;<\/p>\n<\/li>\n
sterilization containers;<\/p>\n<\/li>\n
surgical clogs;<\/p>\n<\/li>\n
wheelchairs, aids for the disabled.<\/p>\n<\/li>\n<\/ol>\n
This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance.<\/p>\n
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO I5883-4, and ISO 15883-6 do not fall within the scope of this part of ISO 15883.<\/p>\n
In addition, the methods are specified, as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs.<\/p>\n
\nNOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended by the device manufacturer.<\/p>\n<\/blockquote>\n
The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.<\/p>\n
PDF Catalog<\/h4>\n
\n
\n PDF Pages<\/th>\n PDF Title<\/th>\n<\/tr>\n \n 4<\/td>\n European foreword
Table \u2014 Correlation between normative references and dated EN and ISO standards <\/td>\n<\/tr>\n\n 6<\/td>\n Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93\/42\/EEC [OJ L 169] aimed to be covered
Table ZA.1 \u2014 Correspondence between this European standard and Annex I of Directive 93\/42\/EEC [OJ L 169] <\/td>\n<\/tr>\n\n 9<\/td>\n Table ZA.2 \u2014 Relevant Essential Health and Safety Requirements from Directive 2006\/42\/EC on machinery that are addressed by this European Standard (according to Article 3 of amended Directive 93\/42\/EEC) <\/td>\n<\/tr>\n \n 15<\/td>\n Foreword <\/td>\n<\/tr>\n \n 16<\/td>\n Introduction <\/td>\n<\/tr>\n \n 17<\/td>\n 1\tScope
2\tNormative references <\/td>\n<\/tr>\n\n 18<\/td>\n 3\tTerms and definitions
4\tPerformance requirements
4.1\tGeneral <\/td>\n<\/tr>\n\n 19<\/td>\n 4.2\tCleaning
4.3\tDisinfection <\/td>\n<\/tr>\n\n 21<\/td>\n 4.4\tFinal rinsing
4.5\tSelf-disinfection <\/td>\n<\/tr>\n\n 22<\/td>\n 4.6\tDrying
4.7\tWater treatment equipment
4.7.1\tGeneral
4.7.2\tDisinfection of water treatment equipment <\/td>\n<\/tr>\n\n 23<\/td>\n 4.7.3\tMaintenance of piping
5\tMechanical requirements
5.1\tMaterials \u2014 Design, manufacture, and assembly
5.2\tProcess verification
6\tTesting for conformity
6.1\tGeneral <\/td>\n<\/tr>\n\n 24<\/td>\n 6.2\tTest load
6.2.1\tLoading with standard goods
6.2.2\tLoading with special goods
6.3\tWater used for rinsing following disinfection
6.4\tLoad dryness
6.4.1\tGeneral
6.4.2\tProcedure
6.4.3\tResults
6.5\tThermometric tests
6.5.1\tGeneral
6.5.2\tLoad temperature test <\/td>\n<\/tr>\n\n 25<\/td>\n 6.6\tChemical dosing tests
6.6.1\tGeneral
6.6.2\tReused process chemicals
6.7\tTests of cleaning efficacy
6.7.1\tGeneral
6.7.2\tMaterials <\/td>\n<\/tr>\n\n 26<\/td>\n 6.7.3\tProcedure
6.7.4\tResults
6.8\tTest of disinfection efficacy
6.8.1\tGeneral
6.8.2\tPreliminary tests on chemical disinfectants <\/td>\n<\/tr>\n\n 27<\/td>\n 6.8.3\tSelf-disinfection tests <\/td>\n<\/tr>\n \n 28<\/td>\n 6.8.4\tChemical disinfection of the load
7\tDocumentation
8\tInformation to be provided by the manufacturer <\/td>\n<\/tr>\n\n 29<\/td>\n 9\tMarking, labelling, and packaging
10\tInformation to be requested from the purchaser by the manufacturer <\/td>\n<\/tr>\n\n 30<\/td>\n Annex\u00a0A (normative) Summary of test programmes <\/td>\n<\/tr>\n \n 32<\/td>\n Annex\u00a0B (normative) Methods for microbiological evaluation of disinfection of liquid transport system <\/td>\n<\/tr>\n \n 37<\/td>\n Annex\u00a0C (normative) Tests for microbiological contamination of post-disinfection rinse water <\/td>\n<\/tr>\n \n 38<\/td>\n Annex\u00a0D (normative) Preparation and evaluation of indicators for microbiological testing of the efficacy of chemical disinfection of the load <\/td>\n<\/tr>\n \n 42<\/td>\n Annex\u00a0E (informative) Examples of test locations for the tests with biological indicators <\/td>\n<\/tr>\n \n 46<\/td>\n Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Washer-disinfectors – Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment<\/b><\/p>\n
\n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n BSI<\/b><\/a><\/td>\n 2016<\/td>\n 50<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279312,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[155,2641],"product_tag":[],"class_list":{"0":"post-279306","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-10","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\/279306","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\/279312"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279306"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279306"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279306"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}