Cart (0)
  • No items in cart.
Subtotal
$0
There is a technical issue about last added item. You can click "Report to us" button to let us know and we resolve the issue and return back to you or you can continue without last item via click to continue button.
Search book title
Enter keywords for book title search
Search book content
Enter keywords for book content search
Filters:
FORMAT
BOOKS
PACKAGES
EDITION
to
PUBLISHER
(1)
(316)
(569)
(43)
(234)
(969)
(643)
(1935)
(64)
(91921)
(54)
(535)
(117)
(28)
(20)
(19)
(92193)
(3)
(17)
(1)
(351)
(298)
(6023)
(239)
(16)
(5)
(1619)
(16)
(18)
(28)
(4)
 
(6)
(7)
(115)
(3)
(57)
(5)
(5)
(1)
(1)
(2)
(23)
(26)
(27)
(13)
(61)
(24)
(22)
(7)
(8)
(20)
(1)
(3)
(50)
(6)
(31)
CONTENT TYPE
 Act
 Admin Code
 Announcements
 Bill
 Book
 CADD File
 CAN
 CEU
 Charter
 Checklist
 City Code
 Code
 Commentary
 Comprehensive Plan
 Conference Paper
 County Code
 Course
 DHS Documents
 Document
 Errata
 Executive Regulation
 Federal Guideline
 Firm Content
 Guideline
 Handbook
 Interpretation
 Journal
 Land Use and Development
 Law
 Legislative Rule
 Local Amendment
 Local Code
 Local Document
 Local Regulation
 Local Standards
 Manual
 Model Code
 Model Standard
 Notice
 Ordinance
 Other
 Paperback
 PASS
 Periodicals
 PIN
 Plan
 Policy
 Product
 Program
 Provisions
 Requirements
 Revisions
 Rules & Regulations
 Standards
 State Amendment
 State Code
 State Manual
 State Plan
 State Standards
 Statute
 Study Guide
 Supplement
 Technical Bulletin
 All
  • BSI
    BS EN ISO 11135:2014+A1:2019 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
    Edition: 2020
    $572.14
    / user per year

Description of BS EN ISO 11135:2014+A1:2019 2020

1.1 Inclusions

This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

NOTE 1 Among the similarities are the common need for quality systems, staff training, and proper safety measures. The major differences relate to the unique physical and organizational conditions in health care facilities, and to the initial condition of reusable medical devices being presented for sterilization.

NOTE 2 Health care facilities differ from medical device manufacturers in the physical design of processing areas, in the equipment used, and in the availability of personnel with adequate levels of training and experience. The primary function of the health care facility is to provide patient care; medical device reprocessing is just one of a myriad of activities that are performed to support that function.

NOTE 3 In terms of the initial condition of medical devices, medical device manufacturers generally sterilize large numbers of similar medical devices that have been produced from virgin material. Health care facilities, on the other hand, must handle and process both new medical devices and reusable medical devices of different descriptions and with varying levels of bioburden. They are therefore faced with the additional challenges of cleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this International Standard, alternative approaches and guidance specific to health care facilities are identified as such.

NOTE 4 EO gas and its mixtures are effective sterilants that are primarily used for heat- and/or moisture-sensitive medical devices that cannot be moist heat sterilized.

NOTE 5 Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other health care products.

1.2 Exclusions

1.2.1

This International Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

NOTE See ISO 22442‑1 , ISO 22442‑2 and ISO 22442‑3 .

1.2.2

This International Standard does not detail a specified requirement for designating a medical device as sterile.

NOTE Attention is drawn to national or regional requirements for designating medical devices as “sterile”. See for example EN 556‑1 or ANSI/AAMI ST67.

1.2.3

This International Standard does not specify a quality management system for the control of all stages of production of medical devices.

NOTE The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of a sterilization process for medical devices. Such procedures are commonly considered to be elements of a quality management system. It is not a requirement of this International Standard to have a full quality management system during manufacture or reprocessing. The necessary elements are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485 ) that control all stages of production or reprocessing of medical devices. National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party.

1.2.4

This International Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.

NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations may also exist.

NOTE 2 EO is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of regulations giving safety requirements for handling EO and for premises in which it is used.

1.2.5

This International Standard does not cover sterilization by injecting EO or mixtures containing EO directly into packages or a flexible chamber.

NOTE See ISO 14937 for these types of EO processes.

1.2.6

This International Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products.

NOTE 1 For further information see ISO 10993‑7 .

NOTE 2 Attention is drawn to the possible existence of national or regional regulations specifying limits for the level of EO residues present on or in medical devices.



About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.

X