BS EN ISO 7864-2016 pdf free download.Sterile hypodermic needles for single use — Requirements and test methods (ISO 7864:2016)
It is recommended to use method b) for needles below 0,30 mm and hence no stylets are listed in Table 3 for designated metric sizes below 0,30 mm.
4.14 Sharps injury protection
The needle shall meet the requirements of ISO 23908 when an integrated sharps protection feature is provided.
4.15 Sterility and biocompatibility
4.15.1 Sterility
The needle in its unit packaging shall have been subjected to a validated sterilization process resulting in a Sterility Assurance Level of at least 10 −6 in accordance with recognized ISO standards.
4.15.2 Biocompatibility
The needle shall be free from biological hazard in accordance with the requirements of ISO 10993-1.
5 Packaging
5.1 Unit packaging
Each hypodermic needle shall be sealed in a unit package. The material and design of this packaging shall be such as to ensure that the colour coding of the contents is visible.
The materials of the packaging shall not have detrimental effects on the contents. The materials and design of this container shall be such as to ensure:
a) the maintenance of sterility of the contents under dry, clean and adequately ventilated storage conditions;
b) the minimum risk of contamination of the contents during removal from the container;
c) adequate protection of the contents during normal handling, transit and storage;
d) that once opened, the container cannot be easily resealed, and it shall be obvious that the container has been opened.
5.2 User packaging
Multiple items of unit packaging shall be packed in a user packaging.
User packaging shall be sufficiently robust to protect the contents during handling, transit and storage.
Multiple items of user packaging may be packaged in a storage and/or a transit container.
6 Information supplied by the manufacturer
6.1 General
The needle shall be accompanied by the information that is sufficient for its safe use, taking account of the training and knowledge of potential users. However, for general application hypodermic needles, it is recognized that no instructions for use are supplied. The information shall include the identity of the manufacturer.
6.2 Unit packaging
The unit packaging shall be marked with at least the following information:
a) a description of the contents, including the designated metric size in accordance with 4.6;
b) the word “STERILE” or equivalent, such as symbol for ”Sterile”, ISO 15223-1;
NOTE See ISO 15223-1:2012, symbol number 5.2.1 or symbol number 5.2.2 to 5.2.5 indicating the sterilization method accordingly.
c) an identification reference to the batch code or lot number, prefixed by the symbol for “Batch code“from ISO 15223-1 or the word “LOT”;
NOTE See ISO 15223-1:2012, symbol number 5.1.5.
d) the words “FOR SINGLE USE” or equivalent such as symbol for ”Do not reuse”, ISO 15223-1. The term “disposable“ shall not be used;
NOTE See ISO 15223-1:2012, symbol number 5.4.2.
e) the name and/or tradename of the manufacturer and, where applicable, reference to its authorized representative;
f) the expiry date, if required, prefixed by the ISO 15223-1 symbol “Use-by date”. This symbol shall be accompanied by a date to indicate that the needle should not be used after the end of the year and month. The date shall be expressed as in ISO 8601 as four digits for the year and two digits for the month, YYYY-MM.
NOTE See ISO 15223-1:2012, symbol number 5.1.4.
6.3 User packaging
The user packaging shall be marked with at least the following information:
a) description of the contents, including the designated metric size in accordance with 4.6;
NOTE A description of the contents, including the designated metric size in accordance with 4.6, the quantity, the type or angle of bevel (see NOTE in 4.11) and optionally, the words “regular-walled”, or “thin- walled”, or “extra-thin-walled”, or “ultra-thin-walled” or equivalent or an abbreviation such as RW, TW, ETW, or UTW respectively. b) the word “STERILE” or equivalent, such as symbol for “Sterile”, ISO 15223-1; NOTE See ISO 15223-1:2012, symbol number
5.2.1 or symbol number 5.2.2 to 5.2.5 indicating the sterilization method accordingly.
c) the words “FOR SINGLE USE” or equivalent such as symbol for ”Do not reuse”, ISO 15223-1. The term “disposable“ shall not be used; NOTE See ISO 15223-1:2012, symbol number 5.4.2.
d) a warning to check the integrity of each unit packaging before use;
NOTE See ISO 15223-1:2012, symbol number 5.2.8.
e) an identification reference to the batch code or lot number, prefixed by the symbol for “Batch code“ from ISO 15223-1 or the word “LOT”;
NOTE See ISO 15223-1:2012, symbol number 5.1.5.
f) the expiry date, if required, prefixed by the ISO 15223-1 symbol “Use-by date”. This symbol shall be accompanied by a date to indicate that the needle should not be used after the end of the year and month. The date shall be expressed as in ISO 8601 as four digits for the year and two digits for the month, YYYY-MM. NOTE See ISO 15223-1:2012, symbol number 5.1.4.
g) the name and/or tradename and the address of the manufacturer and, where applicable, reference to its authorized representative; h) information on handling, storage and transportation if no storage container is used for transportation.BS EN ISO 7864 pdf download