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This document specifies common requirements for transportable liquid oxygen systems and specific requirements for base units. Base units are used as a store for liquid oxygen for recharging portable units. They may also, if fitted with a flow outlet and flow selector, be used as a source for the supply of oxygen direct to the patient.

This document specifies requirements for portable units which are part of a transportable liquid oxygen system. These are used as a supply source for oxygen therapy in home-care and in health-care facilities. Portable units are intended to be carried by patients whilst moving around and during their off-site activities and can be refilled from a base unit through a transfilling connector. Portable units are used without professional supervision.

201.1 Scope, object and related standards Clause 1 of the general standard1) 229 applies, except as follows: 230 201.1.1 * Scope 231 Replacement: 232 This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of 233 MEDICAL BEDS as defined in 201.3.214, intended for ADULTS as defined in 201.3.222. Included 234 in scope are both electrical and non-electrical (manual) MEDICAL BEDS with or without 235 adjustable features. 236 This standard does not apply for MEDICAL BEDS intended for CHILDREN covered by IEC 80601- 237 2-89 Medical electrical equipment – Particular requirements for the basic safety and essential 238 performance of medical beds for children. 239 A BED-LIFT and/or a detachable MATTRESS SUPPORT PLATFORM in combination with a compatible 240 non-MEDICAL BED as specified by the MANUFACTURER is also considered a MEDICAL BED. 241 Excluded are devices for which the intended use is mainly for examination or transportation 242 under medical supervision (e.g. stretcher, examination table). 243 This standard does not apply in all requirements to MEDICAL BEDS with special functionality. 244 Beds that are intended to be used for ADULTS with atypical anatomy shall state what atypical 245 anatomies are meant. Additional requirements for the stated atypical anatomies shall be 246 determined in the product RISK MANAGEMENT process and implemented as appropriate in the 247 bed design. 248 EXAMPLE A bed intended for bariatric PATIENTS would require consideration of the differences in anthropomorphic 249 ranges, and having implemented those ranges would label appropriately for the intended PATIENT population. 250 If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to 251 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the 252 case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant. 253 HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within 254 the scope of this standard are not covered by specific requirements in this standard except in 255 7.2.13 and 8.4.1 of the general standard. 

 201.1.1 * Scope 243 Replacement: 244 This standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, 245 hereafter referred to as MEDICAL BEDS as defined in 201.3.219, intended for CHILDREN as defined 246 in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for 247 ADULTS in 201.3.201). 248 This standard applies to electrical or non-electrical MEDICAL BEDS with nonadjustable and 249 electrical / mechanical adjustable functions. 250 This standard applies to MEDICAL BEDS with an INTERNAL LENGTH of up to 180 cm suitable to a 251 body length of 155 cm. 252 NOTE 1 The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with 253 the child or that the bed will be used by an ADULT. 254 If a manufacturer wishes to make a bed that can be used by both a child and an ADULT, e.g. 255 INTERNAL LENGTH of 180 cm or more, then it shall fulfil both IEC 80601-2-52 and this particular 256 standard. 257 This Standard does not apply to: 258 • ADULT only beds covered by IEC 80601-2-52 259 • incubators covered by IEC 60601-2-19; 260 • devices for which the INTENDED USE is mainly for examination or transportation under 261 medical supervision (e.g. stretcher, examination table). 262 If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME 263 SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, 264 the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant. 265 HAZARDS inherent in the intended physiological function of MEDICAL BEDS or ME SYSTEMS within 266 the scope of this standard are not covered by specific requirements in this standard except in 267 7.2.13 and 8.4.1 of the general standard. 

This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

This document establishes the specifications for the dimensions of various endodontic obturating materials including preformed metal, preformed polymeric-coated metal, polymeric points, thermoplastic obturating material or combinations of the above, suitable for use in the obturation of the root canal system. This document also specifies numerical systems and a colour-coding system for designating the sizes of preformed endodontic obturating points. Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers the physical attributes expected of such products as supplied. Sterility is not included in this document, and any claim that the product is sterile is the responsibility of the manufacturer (see Table 3). Clause 7 specifies the labelling needed, including the instructions for use. This document does not apply to instruments or apparatus used in conjunction with thermoplastic obturating materials (obturating material that deform with heat). This document is not applicable to materials for support of a coronal restoration.

This document defines standards for the training of assistance dogs. Assistance dogs may be trained by structured programmes/schools, owner-trained under supervision or ownertrainers. Specifically, this document deals with the following topics: - Preparation of assistance dogs - Socialization and puppy raising of assistance dogs - Training of assistance dogs - Guide Dogs - Hearing Dogs - Mobility Assistance Dogs - PTSD Assistance Dogs - Medical Alert Response Assistance Dogs - Autism and Developmental Disorder Assistance Dogs - Dual Purpose Assistance Dogs

This document specifies test methods and values for sterilization wrap made of - single-use creped paper - single-use nonwoven materials - reusable woven textile materials used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

This document specifies test methods and values for paper used in the manufacture of single-use paper bags (specified in EN 868-4) and in the manufacture of single-use pouches and reels (specified in EN 868-5) used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of sterilization processes that require properties specific to higher temperature sterilization, such as moist heat sterilization used in healthcare facilities. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

This document specifies test methods and values for single-use paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

This document specifies test methods and values for paper used in the manufacture of single-use preformed sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of low temperature sterilization processes. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

This document specifies test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as single-use sterile barrier systems and/or single-use packaging systems for terminally sterilized medical devices by the means of low temperature sterilization processes. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.