EN ISO 14644-5 pdf download Cleanrooms and associated controlled environments – Part 5: Operations (ISO 14644-5:2004)
4.2.1Cleanroom clothing shall protect the environment and products from contamination generated by thepersonnel and their everyday clothing.To maximize this containment, the choice of barrier fabric, the clothingstyle and extent of coverage of personnel by the cleanroom clothing shall be established.
4.2.2 Cleanroom clothing shall be made of fabrics and materials that will resist breakdown(minimalinting)and therefore not shed contamination.
4.2.3 The frequency of changing into fresh cleanroom clothing before entering the cleanroom shall bedetermined in accordance with the product and process cleanliness requirements.
4.2.4 Reusable cleanroom clothing shall be processed at regular intervals to remove contamination.
4.2.5 The necessary cleaning,processing (including sterilization or disinfection where required) andpackaging of clothing shall be defined.
4.2.6 Cleanroom clothing shall be transported and stored in a specified manner to minimize contamination.
4.2.7 Cleanroom clothing (clean packaged or dirty) shall not be removed beyond the confines of the storagearea and cleanroom except for laundering, repair or exchange purposes.
4.2.8 Cleanroom clothing shall be put on and taken off in such a way that the spread of contamination isavoided or minimized.
4.2.9 lf clothing is to be reused, it shall be removed and stored to ensure that contamination is minimized.
4.2.10 Cleanroom clothing shall be checked at regular intervals to ensure that it retains acceptablecontamination control characteristics.
4.2.11 Consideration shall be given for the comfort of personnel wearing the cleanroom clothing.
4.2.12 Consideration shall be given to special (e.g.chemical, physical or microbiological) properties of theclothing that may be necessary for specific applications.
4.2.13 Consideration shall be given to special concems for cleanroom clothing during and after emergencyevacuations.
NOTE Informative guidance concerning cleanroom clothing requirements listed in 4.2.1 to 4.2.13 can be found inAnnex B.
4.3.1 Personal and other items not intended for cleanroom use shall not be allowed inside the cleanroom,unless approved.
4.3.2Personnel shall be instructed in hygiene-related issues that will prepare them for properly working inthe cleanroom environment.
4.3.3 A policy concerning jewellery, cosmetics and similar materials that can cause contamination problemsshall be determined.
4.3.4Cleanroom personnel shall be trained to conduct themselves in a manner that minimizes generationof contamination which can be transferred or deposited on or into the product.
4.3.5 Personnel shall be protected against hazards. Personnel shall receive safety training for all knownhealth and safety risks associated with their work.
NOTE Informative guidance concerning personnel requirements listed in 4.3.1 to 4.3.5 can be found in Annex C.
4.4.1All equipment,with its associated moving and rigging equipment,shall be thoroughly cleaned ordecontaminated, or both, before being transported into the cleanroom environment.
4.4.2Procedures relating to the entry of equipment into a controlled environment shall be specified toensure that all equipment undergoes the necessary cleaning and decontaminating.
4.4.3Installation of equipment shall be planned and carried out to minimize the impact on the cleanroomenvironment.
44.4Equipment maintenance, repairs and calibration procedures shall be performed in such a way as tocontrol and minimize contamination of the cleanroom.
4.4.5 Documented procedures relating to maintenance work and repairs shall be specified to controlcontamination.
4.4.6Preventive maintenance schedules shall be established and timed to renew and replace componentsbefore the components become contamination sources.
NOTE Informative guidance concerming stationary equipment requirements listed in 4.4.1 to 4.4.6 can be found inAnnex D.
4.5Materials and portable and mobile equipment
4.5.1 All materials，as well as portable and mobile equipment,shall be appropriate for the level ofcleanroom cleanliness,and in use, shall not compromise the product and process.
4.5.2 Procedures shall be established to ensure materials and portable and mobile equipment entering thecleanroom are not contaminated.
4.5.3 Procedures shall be established to minimize the quantities of materials stored in the cleanroom.Consideration shall be given to shelf-life limitations, if applicable.
4.5.4Materials stored in the cleanroom shall be subject to defined procedures and, where necessary, shallbe held in protective storage or isolation. The risk of contamination arising from the storage and subsequentuse of materials and portable and mobile equipment in the cleanroom shall be considered.
4.5.5 All used and waste materials shall be collected,identified and removed in accordance with definedprocedures. Waste materials shall be removed frequently and in a manner that does not compromise thecleanliness of the product or process. Procedures for hazardous materials must conform to statutoryrequirements set by locall and other regulatory agencies.
NOTE Informative guidance concerning materials and portable equipment requirements listed in 4.5.1 to 4.5.5 can befound in Annex E.
4.6.1 Cleaning methods and procedures shall be specified and routinely followed to maintain cleanroomsurfaces at acceptable cleanliness levels.
4.6.2 Personnel responsible for the cleaning operation shall be designated and receive specific training foraccomplishing the task.
4.6.3 Cleaning schedules shall be defined and carried out at effective frequencies to ensure that specifiedcleanliness levels are maintained.