BS EN ISO 11607-1:2017 pdf free download.Packaging for terminally sterilized medical devices.
1 Scope
This part of ISO 11607 specifles the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are Intended to maintain sterility of terminally sterilized medical devices until the point of use.
This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for d rug/device combinations.
This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.
This part of ISO 11607 does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation olihe item to the site of reprocessing or disposal.
2 NormatIve references
The following referenced documents are Indispensable for the applicatiim of BS EN ISO 11607-1. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 5636-5, Paper mid board — Determination of air permeance and air resistance (medium ran,qe) — PartS: Gurley method
3 Terms and definitions
For the purposes of BS EN ISO 11607-1, the following terms and definitions apply.
a.i
aseptic presentation
introduction and transfer of a sterile product using conditions and procedures that exclude microbial contamination
3.2
bioburden
population of viable microorganisms on or in a product or sterile barner system
[SOURCE: ISO/IS 11139:2006]
3.3
closure
means used to close a sterile barrier system where no seal is formed
Note ito entry: Far example, a sterile bai-rwr system can be closed by a reusable container gasket ,r sequential folding to construct a tortuous path,
3.4
closure Integrity
characteristics of the closure which ensure that It prevents the Ingress of microorganisms, demonstrated under test conditions which consider sterilization process, handling, distribution, transport and storage
explry date
indication at the date, by which the product should be used, expressed at least as the year and month
3.6
labelling
written, printed, electronic or graphic matter affixed to a medical device or its packaging system; or accompanyrng a medical device
Note ito entry: Labelling is reLated to identification, technical description and use of the medic.l device but excludes shipping documents.
3.7
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other related artide, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation [or an inlury;
— investigation, replacement, modification or support of the anatomy or of a physiological process.
— supporting or sustaining lire.
— control of conception.
— disinfection of medical devices,
— providing information for medical purposes by means of in vitro examination of specimens derived from the human body;
and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted In its function by such means
ISOURCE: ISO 13485:20031
Note 1 to entry: This deFinition From ISO 13485:2003 has been developed by the Global Harmonization Task
Force (GH’l’F 2002).
microbial barrier
property of the sterile barrier system which ensures that it prevents the ingress or microorganisms, demonstrated under test conditions which consider sterilization process, handling, distribution, transport and stnrage
packaging material
any material used in the fabrication or sealing of a packaging system
3.16
reproducibility
closeness of the agreement between the results or measurements ci the same particular quantity subfrct to measurement (measurand) carried out under changed conditions of measurement
Note ito entry: A valid statement of reproducibility requires speci(ication o4the conditions changed.
Notc 2 to entry: The changed conditions can include:
— principle of measurement;
— method olmeasuretnent;
— observer;
— measuring Instrument;
— reference standard; location;
— conditions of use;
— time.
Note 3 to entry: Reproducibility may he expressed quantitatively in terms of the dispersion characteristics of the results.
Note 4 to entry: Adapted from International Vocabulary of Basic and Cenerol Terms In Metrology. 1993, delmltion 3.7.
3.17
reusable container
rigid sterile barrier system designed to be repeatedly used
3.18
seal
result of olnlng surfaces together
Note 1 to entry: For example, surfaces can be pointed together hy use at adhesives or thermal fusion.
3.19
seal Integrity
characteristic of the seal which ensures that it prevents the ingress of microorganisms, demonstrated under test conditions which consider sterilization process, handling, distribution, transport and storage
3,20
seal strength
mechanical strength of the seal
3.21
sterile
free from viable microorganisms
SOURCE: ISO/TS 11139:20061
3,22
sterile barrier system
minimum package that prevents Ingress of microorganisms and allows aseptic presentation of the product at the point of use
(SOURCE: ISO/TS 11139:2006)
e) compatibility with respect to the intended sterilization process(es) (see 5.3);
f) any shelf•IiIe limitations for pre-sterilization and post-sterilization storage.
5.1.7 Materials, e.g. wrapping materials, paper, plastic film, nonwovcns or reusable fabrics. shall meet the following general performance requirements.
a) Materials shall be non-leaching and odourless under specified conditions of use, to such an extent that neither performance nor safety is Impaired and the medical devices with which they are in contact are not adversely affected.
NOTE Odour determination does not require a standardized test method, since objectionable odours are readily evident
b) Materials shall be free of holes, cracks, tears, creases or localized thickening and/or thinning sufficient to impair functioning.
c) Materials shall have a basis weight (mass per unit area) which is consistent with the specified value,
d) Materials shall exhibit acceptable levels of cleanliness, particulate matter and linting.
e) Materials shall comply with established specific or minimum physical properties, such as tensile strength, thickness variation, tear resistance, air permeance and burst strength.
1) Materials shall comply with established specific chemical characteristics (such as pH value, chloride, and sulfate content) to meet the requirements ci the medical device, packaging system or sterilization process.
2) Materials shall not contain or release material known to be toxic In sufficient quantity to cause a health hazard either before, during or after sterilization under the conditions of use.
51.8 In addition to the requirements given in 5.1.1 through £1.7.. adhesive-coated materials shall meet the requirements listed below.
a) Coating patterns shall be continuous without skips or breaks in the pattern sufficient to cause a discontinuity In the seal.
b) Coating mass shall be consistent with the stated value.
c) Materials shall demonstrate minimum specified seal strength when a seal is formed with another specified material under specified conditions.
5.1.9 In addition to the requirements given in £1.1 through £1.7 and, if appropriate. 5.L. sterile barrier systems and preformed sterile barrier systems shall meet the requirements listed below.
a) Materials and components. e.g. coatings, ink or chemical indicators, shall not adversely affect the medical device by reaction, contamination and/or transfer before, during or after the defined sterilization process.
b) If formed by sealing. the specified requirements for seal width and seal strength (tensile and/or burst) shall be met.
c) Peel-open characteristics shall be continuous and homogeneous, without delamination or tearing of the material that can affect aseptic opening and presentation.
NOTE I Paper bags and heat-sealable pouches and reds have construction and design requirements, as well as performance requirements.
NOTE Z A maximum seal strength may he necessary, IlseaLs are Intended to be opened for aseptic presentation.
d) Seals and/or closures shall provide a barrier to microorganisms.