{"id":279469,"date":"2024-10-19T18:51:46","date_gmt":"2024-10-19T18:51:46","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-111352014\/"},"modified":"2024-10-25T15:25:40","modified_gmt":"2024-10-25T15:25:40","slug":"bs-en-iso-111352014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-111352014\/","title":{"rendered":"BS EN ISO 11135:2014"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\nSection sec_1
Section sec_1.1
Section sec_1.2
Section sec_1.2.1
Section sec_1.2.2
Section sec_1.2.3
1\tScope
1.1\tInclusions
1.2\tExclusions <\/td>\n<\/tr>\n
14<\/td>\nSection sec_1.2.4
Section sec_1.2.5
Section sec_1.2.6
Section sec_2
2\tNormative references <\/td>\n<\/tr>\n
15<\/td>\nSection sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
3\tTerms and definitions <\/td>\n<\/tr>\n
16<\/td>\nSection sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13
Section sec_3.14
Section sec_3.15
Section sec_3.16 <\/td>\n<\/tr>\n
17<\/td>\nSection sec_3.17
Section sec_3.18
Section sec_3.19
Section sec_3.20
Section sec_3.21
Section sec_3.22 <\/td>\n<\/tr>\n
18<\/td>\nSection sec_3.23
Section sec_3.24
Section sec_3.25
Section sec_3.26
Section sec_3.27
Section sec_3.28
Section sec_3.29 <\/td>\n<\/tr>\n
19<\/td>\nSection sec_3.30
Section sec_3.31
Section sec_3.32
Section sec_3.33
Section sec_3.34
Section sec_3.35
Section sec_3.36
Section sec_3.37
Section sec_3.38 <\/td>\n<\/tr>\n
20<\/td>\nSection sec_3.39
Section sec_3.40
Section sec_3.41
Section sec_3.42 <\/td>\n<\/tr>\n
21<\/td>\nSection sec_3.43
Section sec_3.44
Section sec_3.45
Section sec_3.46
Section sec_3.47
Section sec_3.48
Section sec_3.49 <\/td>\n<\/tr>\n
22<\/td>\nSection sec_3.50
Section sec_3.51
Section sec_3.52
Section sec_3.53
Section sec_3.54
Section sec_3.55
Section sec_3.56
Section sec_3.57 <\/td>\n<\/tr>\n
23<\/td>\nSection sec_3.58
Section sec_4
Section sec_4.1
Section sec_4.1.1
Section sec_4.1.2
Section sec_4.2
Section sec_4.2.1
Section sec_4.2.2
Section sec_4.3
Section sec_4.3.1
Section sec_4.3.2
Section sec_4.3.3
Section sec_4.4
Section sec_5
Section sec_5.1
4\tQuality management systems
4.1\tDocumentation
4.2\tManagement responsibility
4.3\tProduct realization
4.4\tMeasurement, analysis and improvement\u00a0\u2014 Control of nonconforming product
5\tSterilizing agent characterization
5.1\tGeneral <\/td>\n<\/tr>\n
24<\/td>\nSection sec_5.2
Section sec_5.3
Section sec_5.4
Section sec_5.5
Section sec_5.5.1
Section sec_5.5.2
Section sec_5.5.3
Section sec_6
Section sec_6.1
Section sec_6.1.1
Section sec_6.1.2
Section sec_6.2
Section sec_6.2.1
5.2\tSterilizing agent
5.3\tMicrobicidal effectiveness
5.4\tMaterial effects
5.5\tSafety and the environment
6\tProcess and equipment characterization
6.1\tGeneral
6.2\tProcess characterization <\/td>\n<\/tr>\n
25<\/td>\nSection sec_6.2.2
Section sec_6.2.3
Section sec_6.2.4
Section sec_6.2.5
Section sec_6.3
Section sec_6.3.1
6.3\tEquipment characterization <\/td>\n<\/tr>\n
26<\/td>\nSection sec_6.3.2
Section sec_6.3.3
Section sec_6.3.4
Section sec_6.3.5
Section sec_7
Section sec_7.1
Section sec_7.1.1
Section sec_7.1.2
Section sec_7.1.3
Section sec_7.1.4
Section sec_7.1.5
7\tProduct definition
7.1\tGeneral <\/td>\n<\/tr>\n
27<\/td>\nSection sec_7.1.6
Section sec_7.2
Section sec_7.2.1
Section sec_7.2.2
Section sec_7.2.3
Section sec_7.2.4
Section sec_7.3
Section sec_7.3.1
Section sec_7.3.2
Section sec_7.4
Section sec_8
Section sec_8.1
Section sec_8.2
Section sec_8.3
7.2\tProduct safety, quality and performance
7.3\tMicrobiological quality
7.4\tDocumentation
8\tProcess definition <\/td>\n<\/tr>\n
28<\/td>\nSection sec_8.4
Section sec_8.5
Section sec_8.6
Section sec_8.7
Section sec_8.8
Section sec_8.9
Section sec_9
Section sec_9.1
Section sec_9.1.1
Section sec_9.1.2
Section sec_9.1.3
9\tValidation
9.1\tGeneral <\/td>\n<\/tr>\n
29<\/td>\nSection sec_9.1.4
Section sec_9.2
Section sec_9.2.1
Section sec_9.2.1.1
Section sec_9.2.1.2
Section sec_9.2.1.3
Section sec_9.2.2
Section sec_9.2.2.1
Section sec_9.2.2.2
Section sec_9.2.2.3
Section sec_9.2.2.4
Section sec_9.2.2.5
Section sec_9.2.2.6
Section sec_9.3
Section sec_9.3.1
9.2\tInstallation qualification, IQ
9.3\tOperational qualification, OQ <\/td>\n<\/tr>\n
30<\/td>\nSection sec_9.3.2
Section sec_9.4
Section sec_9.4.1
Section sec_9.4.1.1
Section sec_9.4.1.2
Section sec_9.4.1.3
Section sec_9.4.1.4
Section sec_9.4.1.5
Section sec_9.4.1.6
Section sec_9.4.1.7
Section sec_9.4.1.8
Section sec_9.4.1.9
Section sec_9.4.1.10
Section sec_9.4.2
Section sec_9.4.2.1
Section sec_9.4.2.2
9.4\tPerformance qualification, PQ <\/td>\n<\/tr>\n
31<\/td>\nSection sec_9.4.2.3
Section sec_9.4.2.4
Section sec_9.4.2.5
Section sec_9.4.2.6
Section sec_9.4.3
Section sec_9.4.3.1
Section sec_9.4.3.2 <\/td>\n<\/tr>\n
32<\/td>\nSection sec_9.5
Section sec_9.5.1
Section sec_9.5.2
Section sec_9.5.3
Section sec_9.5.4
9.5\tReview and approval of validation <\/td>\n<\/tr>\n
33<\/td>\nSection sec_9.5.5
Section sec_9.5.6 <\/td>\n<\/tr>\n
34<\/td>\nSection sec_10
Section sec_10.1
Section sec_10.2
Section sec_10.3
10\tRoutine monitoring and control <\/td>\n<\/tr>\n
35<\/td>\nSection sec_10.4
Section sec_10.5
Section sec_11
Section sec_11.1
Section sec_11.2
Section sec_11.3
Section sec_11.4
Section sec_12
Section sec_12.1
Section sec_12.1.1
11\tProduct release from sterilization
12\tMaintaining process effectiveness
12.1\tGeneral <\/td>\n<\/tr>\n
36<\/td>\nSection sec_12.1.2
Section sec_12.2
Section sec_12.2.1
Section sec_12.2.2
Section sec_12.2.3
Section sec_12.2.4
Section sec_12.3
Section sec_12.3.1
Section sec_12.3.2
Section sec_12.3.3
Section sec_12.3.4
Section sec_12.4
Section sec_12.4.1
Section sec_12.4.2
Section sec_12.4.3
Section sec_12.4.4
12.2\tMaintenance of equipment
12.3\tRequalification
12.4\tAssessment of change <\/td>\n<\/tr>\n
37<\/td>\nSection sec_12.4.5
Section sec_12.4.6
Section sec_12.5
Section sec_12.5.1
Section sec_12.5.2
12.5\tAssessment of equivalence <\/td>\n<\/tr>\n
38<\/td>\nAnnex sec_A
Annex sec_A.1
Annex sec_A.1.1
Annex sec_A.1.2
Annex sec_A.1.3
Annex sec_A.2
Annex\u00a0A
\n(normative)<\/p>\n

Determination of lethal rate of the sterilization process\u00a0\u2014 Biological indicator\/bioburden approach <\/td>\n<\/tr>\n

39<\/td>\nAnnex sec_B
Annex sec_B.1
Annex sec_B.1.1
Annex sec_B.1.2
Annex sec_B.1.3
Annex sec_B.1.4
Annex sec_B.2
Annex sec_B.2.1
Annex sec_B.2.2
Annex\u00a0B
\n(normative)<\/p>\n

Conservative determination of lethal rate of the sterilization process\u00a0\u2014 Overkill approach <\/td>\n<\/tr>\n

40<\/td>\nAnnex sec_B.2.3
Annex sec_B.2.4
Annex sec_B.2.5 <\/td>\n<\/tr>\n
41<\/td>\nAnnex sec_C
Annex sec_C.1
Table tab_C.1
Annex sec_C.2
Annex\u00a0C
\n(informative)<\/p>\n

Temperature sensors, RH sensors and biological indicator numbers <\/td>\n<\/tr>\n

42<\/td>\nTable tab_C.2
Annex sec_C.3 <\/td>\n<\/tr>\n
43<\/td>\nTable tab_C.3 <\/td>\n<\/tr>\n
44<\/td>\nAnnex sec_D
Annex sec_D.1
Annex sec_D.2
Annex sec_D.3
Annex sec_D.4
Annex sec_D.4.1
Annex sec_D.4.2
Annex sec_D.4.2.1
Annex sec_D.4.2.2
Annex\u00a0D
\n(informative)<\/p>\n

Guidance on the application of the normative requirements <\/td>\n<\/tr>\n

45<\/td>\nAnnex sec_D.4.3
Annex sec_D.4.3.1
Annex sec_D.4.3.2
Annex sec_D.4.3.3
Annex sec_D.4.4
Annex sec_D.5
Annex sec_D.5.1 <\/td>\n<\/tr>\n
46<\/td>\nAnnex sec_D.5.2
Annex sec_D.5.3
Annex sec_D.5.4
Annex sec_D.5.5
Annex sec_D.5.5.1
Annex sec_D.5.5.2 <\/td>\n<\/tr>\n
47<\/td>\nAnnex sec_D.5.5.3
Annex sec_D.6
Annex sec_D.6.1
Annex sec_D.6.2
Annex sec_D.6.2.1
Annex sec_D.6.2.2 <\/td>\n<\/tr>\n
48<\/td>\nAnnex sec_D.6.2.3
Annex sec_D.6.2.4 <\/td>\n<\/tr>\n
49<\/td>\nAnnex sec_D.6.2.5
Annex sec_D.6.3
Annex sec_D.6.3.1 <\/td>\n<\/tr>\n
50<\/td>\nAnnex sec_D.6.3.2 <\/td>\n<\/tr>\n
51<\/td>\nAnnex sec_D.6.3.3
Annex sec_D.6.3.4
Annex sec_D.6.3.5
Annex sec_D.7
Annex sec_D.7.1
Annex sec_D.7.1.1 <\/td>\n<\/tr>\n
52<\/td>\nAnnex sec_D.7.1.2 <\/td>\n<\/tr>\n
53<\/td>\nAnnex sec_D.7.1.3
Annex sec_D.7.1.4
Annex sec_D.7.1.5
Annex sec_D.7.1.6 <\/td>\n<\/tr>\n
54<\/td>\nAnnex sec_D.7.2
Annex sec_D.7.2.1 <\/td>\n<\/tr>\n
55<\/td>\nAnnex sec_D.7.2.2
Annex sec_D.7.2.3
Annex sec_D.7.2.4
Annex sec_D.7.3
Annex sec_D.7.3.1
Annex sec_D.7.3.2
Annex sec_D.7.4 <\/td>\n<\/tr>\n
56<\/td>\nAnnex sec_D.8
Annex sec_D.8.1
Annex sec_D.8.2 <\/td>\n<\/tr>\n
57<\/td>\nAnnex sec_D.8.3
Annex sec_D.8.4
Annex sec_D.8.5
Annex sec_D.8.6 <\/td>\n<\/tr>\n
59<\/td>\nAnnex sec_D.8.7
Annex sec_D.8.8
Annex sec_D.8.9
Annex sec_D.9
Annex sec_D.9.1
Annex sec_D.9.1.1 <\/td>\n<\/tr>\n
60<\/td>\nAnnex sec_D.9.1.2
Annex sec_D.9.1.3
Annex sec_D.9.1.4
Annex sec_D.9.2
Annex sec_D.9.2.1
Annex sec_D.9.2.1.1 <\/td>\n<\/tr>\n
61<\/td>\nAnnex sec_D.9.2.1.2
Annex sec_D.9.2.1.3
Annex sec_D.9.2.2
Annex sec_D.9.2.2.1
Annex sec_D.9.2.2.2
Annex sec_D.9.2.2.3
Annex sec_D.9.2.2.4
Annex sec_D.9.2.2.5 <\/td>\n<\/tr>\n
62<\/td>\nAnnex sec_D.9.2.2.6
Annex sec_D.9.3
Annex sec_D.9.3.1
Annex sec_D.9.3.2 <\/td>\n<\/tr>\n
63<\/td>\nAnnex sec_D.9.4
Annex sec_D.9.4.1
Annex sec_D.9.4.1.1
Annex sec_D.9.4.1.2
Annex sec_D.9.4.1.3
Annex sec_D.9.4.1.4 <\/td>\n<\/tr>\n
64<\/td>\nAnnex sec_D.9.4.1.5
Annex sec_D.9.4.1.6
Annex sec_D.9.4.1.7
Annex sec_D.9.4.1.8
Annex sec_D.9.4.1.9
Annex sec_D.9.4.1.10
Annex sec_D.9.4.2
Annex sec_D.9.4.2.1 <\/td>\n<\/tr>\n
65<\/td>\nAnnex sec_D.9.4.2.2
Annex sec_D.9.4.2.3
Annex sec_D.9.4.2.4
Annex sec_D.9.4.2.5
Annex sec_D.9.4.3 <\/td>\n<\/tr>\n
66<\/td>\nAnnex sec_D.9.4.3.1
Annex sec_D.9.4.3.2 <\/td>\n<\/tr>\n
67<\/td>\nAnnex sec_D.9.4.4
Annex sec_D.9.5.1
Annex sec_D.9.5.2
Annex sec_D.9.5.3
Annex sec_D.9.5.4
Annex sec_D.9.5.5
Annex sec_D.9.5.6 <\/td>\n<\/tr>\n
68<\/td>\nAnnex sec_D.10
Annex sec_D.10.1
Annex sec_D.10.2 <\/td>\n<\/tr>\n
69<\/td>\nAnnex sec_D.10.3
Annex sec_D.10.4
Annex sec_D.10.5 <\/td>\n<\/tr>\n
70<\/td>\nAnnex sec_D.11
Annex sec_D.11.1
Annex sec_D.11.2
Annex sec_D.11.3 <\/td>\n<\/tr>\n
71<\/td>\nAnnex sec_D.11.4
Annex sec_D.11.5
Annex sec_D.12
Annex sec_D.12.1
Annex sec_D.12.1.1
Annex sec_D.12.1.2 <\/td>\n<\/tr>\n
72<\/td>\nAnnex sec_D.12.2
Annex sec_D.12.2.1
Annex sec_D.12.2.2
Annex sec_D.12.2.3
Annex sec_D.12.2.4
Annex sec_D.12.3
Annex sec_D.12.3.1 <\/td>\n<\/tr>\n
73<\/td>\nAnnex sec_D.12.3.2
Annex sec_D.12.3.3 <\/td>\n<\/tr>\n
74<\/td>\nFigure fig_D.1
Annex sec_D.12.3.4 <\/td>\n<\/tr>\n
75<\/td>\nAnnex sec_D.12.3.5
Annex sec_D.12.4
Annex sec_D.12.4.1
Annex sec_D.12.4.2
Annex sec_D.12.4.3
Annex sec_D.12.4.4
Annex sec_D.12.4.5
Annex sec_D.12.4.6
Annex sec_D.12.5
Annex sec_D.12.5.1 <\/td>\n<\/tr>\n
76<\/td>\nAnnex sec_D.12.5.2
Annex sec_D.12.5.3
Annex sec_D.12.5.4 <\/td>\n<\/tr>\n
77<\/td>\nAnnex sec_D.12.5.5
Annex sec_D.12.5.6 <\/td>\n<\/tr>\n
78<\/td>\nAnnex sec_D.12.5.7
Annex sec_D.12.5.8
Annex sec_D.12.5.9
Annex sec_D.12.5.10 <\/td>\n<\/tr>\n
79<\/td>\nAnnex sec_D.12.5.11
Annex sec_D.12.5.11.1
Annex sec_D.12.5.11.2 <\/td>\n<\/tr>\n
80<\/td>\nAnnex sec_D.12.5.11.3
Annex sec_D.12.5.11.4
Annex sec_D.12.5.11.5
Annex sec_D.12.5.11.6
Annex sec_D.12.5.11.7 <\/td>\n<\/tr>\n
81<\/td>\nAnnex sec_D.13
Annex sec_D.13.1
Annex sec_D.13.1.1 <\/td>\n<\/tr>\n
82<\/td>\nAnnex sec_D.13.1.2
Annex sec_D.13.1.3
Annex sec_D.13.2 <\/td>\n<\/tr>\n
83<\/td>\nAnnex sec_D.14
Annex sec_D.14.1
Annex sec_D.14.1.1 <\/td>\n<\/tr>\n
84<\/td>\nAnnex sec_D.14.1.2
Annex sec_D.14.1.3
Annex sec_D.14.1.4
Annex sec_D.14.2
Annex sec_D.14.2.1
Annex sec_D.14.2.2
Annex sec_D.14.2.3
Annex sec_D.14.2.4 <\/td>\n<\/tr>\n
85<\/td>\nAnnex sec_D.14.2.5 <\/td>\n<\/tr>\n
86<\/td>\nAnnex sec_E
Annex sec_E.1
Annex sec_E.2
Annex sec_E.2.1
Annex sec_E.2.2
Annex sec_E.2.3
Annex\u00a0E
\n(normative)<\/p>\n

Single Lot Release <\/td>\n<\/tr>\n

87<\/td>\nAnnex sec_E.2.4 <\/td>\n<\/tr>\n
88<\/td>\nReference ref_1
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Bibliography <\/td>\n<\/tr>\n
89<\/td>\nReference ref_22
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Reference ref_39 <\/td>\n<\/tr>\n
90<\/td>\nReference ref_40
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Reference ref_43 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2015<\/td>\n94<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279473,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-279469","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\/279469","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\/279473"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279469"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279469"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279469"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}