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Sample translations submitted: 3
Chinese to English: ISO 22442-1翻译样本 英中 General field: Medical Detailed field: Medical: Instruments
Source text - Chinese 美国国家标准
ANSI/AAMI/ISO 22442-1:2007
医疗设备用动物组织及其衍生物的应用
第2部分：风险管理
Medical devices utilizing animal tissues and their
derivatives — Part 1: Application of risk management
1 范围
ISO 22442的本部分（以下简称本部分）适用于使用无活性或使无活性生物来源品制造的医疗设备，但不适用于体外诊断医疗设备。本部分结合ISO 14971，规定了与该类设备相关危害及危害处境的界定、造成风险的评价与控制、以及对应控制效果的监视程序。此外，根据ISO 14971的定义，给出了剩余风险的确定程序，以及剩余风险与其它替代品间的医疗受益权衡。本部分重点概述了采用动物组织或其衍生物所制造医疗器械危害相关风险控制的要求和指导，其危害包括：
Translation - English
American National Standard ANSI/AAMI/ISO 22442-1:2007
Medical devices utilizing animal tissues and their
derivatives — Part 1: Application of risk management
1 Scope
This part of ISO 22442 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This part of ISO 22442 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices
manufactured utilizing animal tissues or derivatives such as:
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This part of ISO 22442 does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an International Standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices.
This part of ISO 22442 does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture. However, attention is drawn to International Standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this part of ISO 22442 see Annex A.
Translation - English
COMMONWEALTH OF AUSTRALIA CIVIL AVIATION SAFETY AUTHORITY (Civil Aviation Safety Regulations 1998), PART 39 - 105
SCHEDULE OF AIRWORTHINESS DIRECTIVES
AIRWORTHINESS DIRECTIVE
For the reasons set out in the background section, the CASA delegate whose signature appears below revokes Airworthiness Directive (AD) AD/AS 355/65 and issues the following AD under subregulation 39.1 (1) of CASR 1998. The AD requires that the action set out in the requirement section (being action that the delegate considers necessary to correct the unsafe condition) be taken in relation to the aircraft or aeronautical product mentioned in the applicability section: (a) in the circumstances mentioned in the requirement section; and (b) in accordance with the instructions set out in the requirement section; and (c) at the time mentioned in the compliance section.
Eurocopter AS 355 (Twin Ecureuil) Series Helicopters
Applicability: AS 355 helicopters Versions E, F, F1, F2 and N equipped with Bendix/King KI 525A Horizontal Situation Indicator (HSI).
Requirement: 1. Check the part number (P/N) of the KI 525A HSI installed on the helicopter. Initially, no further action is necessary if the P/N is not 066-3046-07.
2. If the P/N is 066-3046-07, modify the HSI installation in accordance with Eurocopter Alert Telex 34.00.09 paragraph 2.A.1, for helicopters with the HSI connected to a single navigation system, or paragraph 2.A.2, for helicopters with the HSI connected to at least two navigation systems.
Note 1: Modification ion accordance with Eurocopter Alert Service Bulletin (ASB) 34.00.09 is considered acceptable for compliance with Requirement 2.
3. Before installing a KI 525A HSI P/N 066-3046-07 in place of a KI 525A HSI with P/Ns 066-3046-00, -01, -04 or -05 ensure that the HSI installation is modified in accordance with Requirement 2.
Note 2: DGAC AD F-2002-280-068 R1 refers.
Compliance: For Requirement 1 - Remains unchanged as ‘Either within 100 hours time in service after the effective date of the original issue of this Directive or before 10 August 2003, whichever occurs first’.
For Requirement 2 - Before further flight after the Requirement 1 check.
For Requirement 3 - As of the effective date of this Amendment.
This Amendment becomes effective on 10 June 2004.
Background: Eurocopter has advised the French Direction Générale de l’Aviation Civile that KI 525A HSIs P/N 066-3046-07 may have been incorrectly installed on some helicopters. The incorrect installation may result in navigation errors.
The original issue of this Directive introduced measures to ensure that the affected HSIs were correctly installed.
COMMONWEALTH OF AUSTRALIA CIVIL AVIATION SAFETY AUTHORITY (Civil Aviation Safety Regulations 1998), PART 39 - 105
SCHEDULE OF AIRWORTHINESS DIRECTIVES
Eurocopter AS 355 (Twin Ecureuil) Series Helicopters
AD/AS 355/65 Amdt 1 (continued)
This Amendment contains some minor editorial amendments, together with allowing credit for modifications carried out in accordance with the ASB and introduces measures to ensure that the helicopter is modified prior to the installation of a KI 525A HSI P/N 066-3046-07.
The original issue of this Airworthiness Directive became effective on 5 June 2003.
James Coyne
Delegate of the Civil Aviation Safety Authority
30 April 2004
The above AD is notified in the Commonwealth of Australia Gazette on 19 May 2004.
Chinese to English: 铀矿勘探报告翻译样品 英中 General field: Science Detailed field: Mining & Minerals / Gems
Source text - Chinese Initial Reconnaissance:
Plotted results of the airborne radiometric survey, carried out by Messina (Transvaal) Development Company on behalf of African Selection Trust Exploration over an area associated with pans located in the ancient Koa River drainage. Two of the anomalies occur on the farm Dirks-Kop, at present under option to A.S.T.E., and a third on the portion of Gal-Puts under option to A.S.T.E. An initial ground reconnaissance scintillometer survey confirmed the location of these anomalies. Carnotite in calcrete has now been exposed in all three occurrences. The most promising anomaly, pan no.3 on dirks-Kop (refer attached map) is at present being investigated by pitting and trenching. A total of 10 grab samples has shown the uranium content to vary from 0.017% to 0.05%. This pan has a very small surface expression being largely covered with sand and sheetwash.
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