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MDR ABBEX Ⅰ 要求事項 |
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| No |
項番 |
タイトル（E) |
要求事項（E) |
タイトル（J) |
要求事項（J) |
コマンド |
1 | | GENERAL REQUIREMENTS | | 一般要求事項（Chapter1) | | | 2 | 1 | (GENERAL REQUIREMENTS) | Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. | （一般要求事項） | 機器は製造業者が意図した性能を達成しなければならず、意図された目的に適するように設計/生産されなければならない。機器は安全で有効でなければならず、患者の臨床状態や安全、また使用者やその他の者の安全と健康を損なってはならない。 | | 3 | 2 | (reduce risks) | The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio. | （リスクの低減） | リスクを可能な限り低減するという要求は、ベネフィット・リスク比を悪化させずにリスクを可能な限り低減することを意味する。 | | 4 | 3 | (risk management system) | Manufacturers shall establish, implement, document and maintain a risk management system.
Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. In carrying out risk management manufacturers shall:
(a) establish and document a risk management plan for each device;
(b) identify and analyse the known and foreseeable hazards associated with each device;
(c) estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;
(d) eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;
(e) evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability; and
(f) based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Section 4. | （リスクマネジメント） | リスク・マネジメント・システムを確立し、実施し、文書化し、維持する。
リスク・マネジメントは機器の全ライフ・サイクルにわたる継続的な反復性のプロセスで、体系的な更新が必要であり、以下のことを行なう:
(a) それぞれの機器のリスク・マネジメント計画を確立し、文書化する;
(b) それぞれの機器に関係する既知の、また予見可能なハザードを同定し、分析する;
(c) 意図する使用と予見可能な誤使用に関係するリスクを推定し、評価する;
(d) それらのリスクを除去もしくは管理する;
(e) 生産段階からの、また市販後調査システムからのハザードやその発生頻度に関する情報の、関連するリスク、総合的なリスク、ベネフィット・リスク比の推定、そしてリスク受容への影響を評価する;
(f) その影響の評価に基づき、必要に応じてリスク管理手段を見直す。 | | 5 | 4 | (Risk control) | Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
(a) eliminate or reduce risks as far as possible through safe design and manufacture;
(b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and
(c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users.
Manufacturers shall inform users of any residual risks. | （リスク管理手段） | 機器の設計と生産のために採用したリスク管理手段は次の安全原則に従う:
(a) 安全な設計と生産を通じて可能な限りリスクを除去もしくは低減し、
(b) それが適切な場合、除去できないリスクに関して警報を含む適当な防護手段を講じ、
(c) 安全のための情報(警告/注意/禁忌) を、そしてそれが適切な場合は使用者の訓練を提供する。
全ての残留リスクを使用者に通知する。 | | 6 | 5 | (use error) | In eliminating or reducing risks related to use error, the manufacturer shall:
(a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
(b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).
| （使用エラーに関係するリスク） | 使用上の誤りに関係するリスクの除去や低減のため、
(a) 機器の人間工学的特徴や機器の使用が意図された環境に関係するリスクを可能な限り低減し、
(b) 意図された使用者の技術的知識、経験、教育、訓練、使用環境、また該当する場合は医学的/物理的状況を考慮する。 | | 7 | 6 | (lifetime of the device) | The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions. | （耐用寿命） | 機器の耐用寿命中にその特性と性能が患者や使用者やその他の者の健康や安全を損なうほどの悪影響を受けてはならない。 | | 8 | 7 | (manufactured and packaged) | Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer. | （輸送・保管） | 機器の輸送/保管中にその特性と性能が悪影響を受けないように設計、生産、包装する。 | | 9 | 8 | (All known and foreseeable risks) | All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use. | （全体のリスク受容可能） | 全ての既知のまた予見可能なリスク、及び望ましくない副作用は最小とし、そのベネフィットを考慮して受容可能なものとする。 | | 10 | 9 | (understood to mean that the device) | For the devices referred to in Annex XVI, the general safety requirements set out in Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product's use which is consistent with a high level of protection for the safety and health of persons. | （医療目的以外の危機のリスク） | この規則の対象となる医療目的以外の機器(Annex XVI でリストされたもの) に対する一般安全要求事項は、その機器がリスクを全く与えないか、もしくは人々の安全と健康の高水準の保護と両立する最大の受容可能なリスクよりも低いリスクを与えるものと考える。 | | 11 | | REQUIREMENTS REGARDING DESIGN AND MANUFACTURE | | 設計と生産に関する要求（ChapterⅡ） | | | 12 | 10 | Chemical, physical and biological properties | | 化学的、物理的、及び生物学的特性 | 化学的，物理的，及び生物学的特性 | | 13 | 10.1 | | Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in Chapter I are fulfilled. Particular attention shall be paid to: | | 機器は、chapter1で言及した特性と性能要件が確実に満たされるように設計および製造されなければならない。以下に特に注意を払う必要がある。 | | 14 | 10.1(a) | | (a) the choice of materials and substances used, particularly as regards toxicity and, where relevant, flammability; | | （a）特に毒性および関連する場合は可燃性に関して、使用される材料および物質の選択 | | 15 | 10.1(b) | | (b) the compatibility between the materials and substances used and biological tissues, cells and body fluids, taking account of the intended purpose of the device and, where relevant, absorption, distribution, metabolism and excretion; | | （b）機器の使用目的、および関連する場合は吸収、分布、代謝および排出を考慮した、使用される材料および物質と生体組織、細胞および体液との適合性。 | |