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7 Posts in this encyclopedia categoryCE Marking
CE marking is the mandatory conformity marking for products placed on the European Economic Area market that fall under CE-relevant legislation. It confirms that the manufacturer has met all applicable EU requirements. CE is not a quality label but a regulatory conformity marking.
Chemical Protective Glove
Chemical protective gloves protect the wearer from contact with hazardous liquid chemicals. They are classified under EN ISO 374-1 into Types A, B, and C, and are PPE Category III. Protection is demonstrated through permeation testing per EN 16523-1. The governing standards are EN ISO 374-1 (Type A/B/C), EN 16523-1 (permeation measurement), and EN ISO 374-2 (penetration testing).
Compliance
Compliance in the corporate context describes adherence to all relevant legal, regulatory, and internal requirements. In the medical device and PPE sector, compliance encompasses conformity with MDR, PPE Regulation, REACH, food law, and other applicable rules.
Conformity
Conformity in the regulatory context describes the alignment of a product, system, or process with the requirements of a standard, specification, or legal act. In EU product law, conformity is the prerequisite for CE marking and placing a product on the market.
Conformity assessment procedure
The conformity assessment procedure is the legally prescribed process a manufacturer must complete before placing their product on the market with CE marking. It includes technical documentation, risk assessment, clinical evaluation (medical devices), and depending on the product class, examination by a Notified Body.
Contact Resistance
Electrical resistance through the glove describes the resistance opposing current flow through a protective glove. It is the key test parameter for antistatic gloves per EN 16350. The limit is less than 1x10^8 ohms to ensure safe dissipation of electrostatic charges in explosive atmospheres (ATEX).
Cytotoxicity
Cytotoxicity is the ability of a substance to damage or destroy cells. In the context of medical devices, material cytotoxicity is tested per ISO 10993-5 to ensure that extractables do not cause cell damage. Cytotoxicity testing is a requirement for medical single-use gloves under EN 455-3.