C46 手术室设备 标准查询与下载
共找到 783 条与 手术室设备 相关的标准，共 53 页
Tracheal tubes designed for laser surgery. Requirements for marking and accompanying information
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011-09-30
- 实施
- 2011-09-30
Medical electrical equipment. Particular requirements for the basic safety and essential performance of operating tables
- ICS
- 11.140
- CCS
- C46
- 发布
- 2011-09-30
- 实施
- 2011-09-30
Medical electrical equipment. Particular requirements for basic safety and essential performance of critical care ventilators
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011-09-30
- 实施
- 2011-09-30
This International Standard specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. This International Standard is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways. Flammability of oropharyngeal airways, for example if flammable anaesthetics, electrosurgical units or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard. This International Standard is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.
Anaesthetic and respiratory equipment. Oropharyngeal airways
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011-08-31
- 实施
- 2011-08-31
Sterile devices of endoscopic variceal ligation for single use
- ICS
- 11.040.30
- CCS
- C46
- 发布
- 2011-07-29
- 实施
Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
- ICS
- 11.040.40
- CCS
- C46
- 发布
- 2011-07-29
- 实施
Anaesthetic and respiratory equipment - Oropharyngeal airways.
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011-07-01
- 实施
- 2011-07-22
The International Standard specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal.
Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2008); German version EN ISO 5364:2011
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011-07
- 实施
This part of ISO 8835 specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems (active AGSSs) intended to reduce exposure of healthcare personnel to anaesthetic gases and vapours while providing patient protection (e.g. against excessive flow and pressure). This part of ISO 8835 also specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems in which the power device is integral with the transfer and receiving system. This part of ISO 8835 does not specify requirements for - disposal systems which are covered by ISO 7396-2, - non-active AGSSs (passive AGSSs), - proximity gas extraction systems (i.e. systems not directly connected to the breathing system or associated equipment), - transfer and receiving systems intended for use with flammable anaesthetic as determined by Annex DD of IEC 60601-2-13:2003.
Inhalational anaesthesia systems. Transfer and receiving systems of active anaesthetic gas scavenging systems
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011-06-30
- 实施
- 2011-06-30
Medical electrical equipment - Part 2-12 : particular requirements for basic safety and essential performance of critical care ventilators.
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011-06-01
- 实施
- 2011-06-11
IEC 60601-1:1998, Clause 1 applies, except as follows. Amendment: This part of ISO 10651 specifies requirements for lung ventilators intended for home care applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment. These ventilators are frequently used in locations where driving power is not reliable and are often supervised by non-healthcare personnel with different levels of training.
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004); German version EN ISO 10651-2:2009
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011-06
- 实施
- 2009-08-01
Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT: intended to be attended by a professional OPERATOR for those PATIENTS who are dependent on mechanical ventilation; and NOTE 1 Such VENTILATORS are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM. intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility. NOTE 2 A critical care VENTILATOR intended for use in transport within a professional healthcare facility is not considered an emergency and transport ventilator. This International Standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a BREATHING SYSTEM, or to a VENTILATOR, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR. This International Standard is not applicable to ME EQUIPMENT or an ME SYSTEM operating in ventilation modes intended for patients who are not dependent on mechanical ventilation. NOTE 3 A critical care VENTILATOR, when operating in such a mode, is not considered LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in IEC 60601-1:2005, 7.2.13 and 8.4.1. NOTE 4 Additional information can be found in IEC 60601-1:2005, 4.2. This International Standard is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT, sleep apnoea therapy ME EQUIPMENT, HOME HEALTHCARE ENVIRONMENT VENTILATORS, ventilatory support ME EQUIPMENT, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs).[26] This International Standard does not specify the requirements for ME EQUIPMENT that is intended solely to augment the ventilation of spontaneously breathing PATIENTS within a professional healthcare facility. This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for anaesthetic applications which are given in ISO 80601-2-13. This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for home care ventilators for ventilator-dependent PATIENTS which are given in ISO 10651-2 1). This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for emergency and transport which are given in ISO 10651-3 2). This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for home-care ventilatory support devices which are given in ISO 10651-6 3).
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011-04-15
- 实施
Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems; (ISO 8835-3:2007 + Amd. 1:2010); German version EN ISO 8835-3:2009 + A1:2010
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011-02
- 实施
- 2011-02-01
Respiratory protective devices. Human factors. Anthropometrics
- ICS
- 13.340.30
- CCS
- C46
- 发布
- 2011-01-31
- 实施
- 2011-01-31
Inhalational anaesthesia systems - Part 3 : transfer and receiving systems of active anaesthetic gas scavenging systems.
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011-01-01
- 实施
- 2011-01-01
This European Standard specifies requirements for connectors intended for use with medical gases. This European Standard specifies the dimensions and the allocation of non-interchangeable screw-threaded (NIST) connectors intended to be used at nominal operating pressures not greater than 1400kPa.
Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases; German version EN 15908:2010
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011-01-01
- 实施
Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009); German version EN ISO 20072:2010
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011-01
- 实施
Professional Qualifications Standard for Self Contained Breathing Apparatus Replenishment Systems Installers, Inspectors and Verifiers
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2011
- 实施
Aerosol drug delivery device design verification. Requirements and test methods
- ICS
- 11.040.10
- CCS
- C46
- 发布
- 2010-12-31
- 实施
- 2010-12-31
