凡自治之物 · LGD 治理学 · 创造术家族 ｜ 评测协议：skill-quality-gate

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⚠️ Disclaimer: AI-assisted; output is decision support, not medical-device registration, compliance or legal advice. Human review required; authoritative conclusions follow regulator decisions and the latest official documents. Text verification date: 2026-09-26 · clause text per the latest official publication.

When to use

When the user needs medical-device test-item derivation and lab-qualification matching. Trigger words: medical device, medtech compliance, test-lab matcher, TH-MED-010, decision support.

Usage

Entry script (run inside the skill dir): test-lab-match-check.py. Parameters in Section IV.

Workflow

1. Trigger: identify a test-lab-match-check task (see When to use).
2. Execute: run test-lab-match-check.py per Usage.
3. Verify: check output / exit code against expectations.
4. Deliver: present results / artifacts.

I. The pain

Before sample submission you assume "just a few items"; when the report comes back you're missing an endpoint and the lab's accreditation doesn't even cover it — re-submitting costs months.

II. What this is

A zero-dependency, deterministic screener. Pass known conditions as parameters; it applies public rule sources and outputs a structured verdict + obligation list + risk notes as JSON IR (machine-readable), directly embeddable in your own pipeline.

• Zero-dependency: Python stdlib only; no third-party packages, no network, no API key.
• Deterministic: same input → same output (no randomness, no model calls).
• Traceable: every conclusion carries its rule-source clause number for human check.
• Offline: runs on intranet, disconnected machines, old hardware.

III. Core

IV. Usage

python test-lab-match-check.py --demo                     # built-in smoke case (recommended first)
python test-lab-match-check.py --json <your args...>     # real verdict

Available args: --device_type / --material / --contact / --sterile / --steril_method / --has_software / --dest

IV-A. Real run (excerpt)

Command python test-lab-match-check.py --device_type active --sterile yes (2026-09-26, Python 3.13.12). Only JSON indentation adjusted for reading; fields and values verbatim.

{
  "tool": "test-lab-match-check",
  "version": "1.0.0",
  "input": {"device_type": "active", "material": null, "contact": null, "sterile": "yes",
            "steril_method": null, "has_software": null, "dest": null},
  "result": {
    "device_type": "active",
    "required_tests": [
      "Biological evaluation · baseline endpoints (cytotoxicity/sensitization/irritation, selected by contact nature and duration)",
      "Electrical safety (GB 9706.1 general + applicable particular standards)",
      "EMC (YY 0505 / YY 9706.102)",
      "Sterilization validation (method must be fixed first: eo / radiation / steam)",
      "Sterile barrier system & packaging validation (ISO 11607 / GB/T 19633)"
    ],
    "lab_qualification": ["CMA", "CNAS"],
    "ref_cycle": "5–15 weeks (rough magnitude; depends on items and lab schedule)",
    "destination": "cn",
    "obligations": ["…3 items (accreditation-scope check / sample finalization consistency / items derived from technical requirements + risk)"],
    "notes": ["…3 items (derived output / cycle is not a commitment / export needs overseas-recognized reports)"],
    "evidence": ["GB/T 16886 series", "GB 9706.1", "YY 0505", "ISO 11135/11137/17665", "ISO 11607", "IEC 62304"],
    "warnings": [
      "No --material given: material class directly affects biocompatibility endpoints and chemical characterization; precision reduced",
      "Sterile declared but no sterilization method: definitive validation standard cannot be given"
    ]
  },
  "rc": 1,
  "error_code": null,
  "aigc_mark": {"standard": "GB 45438-2025", "is_generated": true, "generator": "test-lab-match-check@SynomosAI",
                "content_type": "decision_support_output", "disclaimer": "Decision support, not authoritative; human review required; per latest official documents"}
}

Three-way rc observed: --device_type implant --material metal --contact implant --sterile yes --steril_method eo --dest cn → rc=0; --device_type active --sterile yes → rc=1 (missing material/sterilization method, strict warning); --device_type ivd --contact garbage / --dest jp → rc=2 (bad enum).

V. Boundaries (please read)

• Rule-based verdict only; no legal opinion, no certificate; human review required; final authority rests with regulators/notified bodies.
• Strict on insufficient input: missing --material, sterile-but-no-method etc. are surfaced in warnings (rc=1), never silently loosened.
• Out of scope: innovative devices, drug-device combos, boundary products, nanomaterials — follow official determination procedures.
• Rule versions change; clause numbers are given — verify against latest official text.
• Output is a starting checklist; does not replace product technical requirements, applicable standards list, or expert judgment.

VI. Theory

Gates set standards first — testing is the gate that turns "compliance" into re-auditable data.

Domain anchor: TH-MED-010 · LGD REGISTRY · medical-device full-lifecycle governance (registered · evidenced · gated)

VII. Family collection (by registration workflow)

TH-MED-010 domain · compliance checks · © 2026 SynomosAI · MIT License. AI-assisted (non-natural-person) content; the named institution takes publication responsibility.

中文

⚠️ 免责声明：本工具由 AI 辅助生成，输出为决策支持，不构成医疗器械注册、合规或法律意见。输出请人工复核，正式结论须以主管部门决定与官方最新文件为准。 文本核验日期：2026-09-26 · 条款文本以官方最新发布为准

何时用

• 当用户需要医疗器械检测项目与实验室匹配器相关能力时。
• 触发词：医疗器械、医械合规、医疗器械检测项目与实验室匹配器、判定器、TH-MED-010、决策支持。

用法

调用方式与参数详见正文「## 四、用法」节。 执行步骤见正文「## 七、家族合集（按注册全流程）」节。 入口脚本（在技能目录下执行）：test-lab-match-check.py。

流程

1. 触发：识别医疗器械检测项目与实验室匹配器相关任务（见「何时用」）。
2. 执行：按「用法」运行test-lab-match-check.py。
3. 校验：核对脚本输出/退出码是否符合预期。
4. 交付：向用户呈现结果/产物。

医疗器械检测项目与实验室匹配器

一、痛点

送检前以为项目就那几项，报告拿到手才发现缺一个终点、实验室资质还超范围——重送一轮就是几个月。

二、这是什么

一个零依赖、确定性输出的判定器。你把已知条件以参数传入，它按公开规则源给出结构化判定 + 义务清单 + 风险提示，输出 JSON IR（机器可读），可直接嵌入你自己的流程。

• 零依赖：仅用 Python 标准库，无第三方包、无网络请求、无 API Key。
• 确定性：同一输入永远同一输出（无随机、无模型调用）。
• 可回溯：每条结论附规则源条款号，便于人工核对。
• 离线可用：可在内网、断网、老电脑上运行。

三、判定核心

四、用法

python test-lab-match-check.py --demo                     # 跑内置冒烟案例（推荐先跑这个）
python test-lab-match-check.py --json <你的参数...>        # 正式判定

可用参数：--device_type / --material / --contact / --sterile / --steril_method / --has_software / --dest

四A、真机输出（实跑节选）

实跑命令 python test-lab-match-check.py --device_type active --sterile yes（2026-09-26，Python 3.13.12）。仅调整 JSON 缩进便于阅读，字段与字段值逐字未改（完整原文见做齐报告）。

{
  "tool": "test-lab-match-check",
  "version": "1.0.0",
  "input": {"device_type": "active", "material": null, "contact": null, "sterile": "yes",
            "steril_method": null, "has_software": null, "dest": null},
  "result": {
    "device_type": "active",
    "required_tests": [
      "生物学评价·基础终点（细胞毒性/致敏/刺激，按接触性质与时长选做）",
      "电气安全（GB 9706.1 通用 + 适用专用并列标准）",
      "电磁兼容 EMC（YY 0505 / YY 9706.102）",
      "灭菌验证（须先确定灭菌方式：eo / radiation / steam）",
      "无菌屏障系统与包装验证（ISO 11607 / GB/T 19633）"
    ],
    "lab_qualification": ["CMA（检验检测机构资质认定）", "CNAS（实验室认可）"],
    "ref_cycle": "5–15 周（视项目数量与实验室排期，属量级参考）",
    "destination": "cn",
    "obligations": ["…3 条（认可范围核对 / 样品定型一致 / 项目由技术要求+风险推导）"],
    "notes": ["…3 条（推导结果 / 周期不构成承诺 / 出口需境外认可报告）"],
    "evidence": ["GB/T 16886 系列", "GB 9706.1", "YY 0505", "ISO 11135/11137/17665", "ISO 11607", "IEC 62304"],
    "warnings": [
      "未提供 --material：材料类别直接影响生物相容性终点与化学表征，缺失将降低清单精度",
      "已声明无菌但未指定灭菌方式，无法给出确定的验证标准"
    ]
  },
  "rc": 1,
  "error_code": null,
  "aigc_mark": {"standard": "GB 45438-2025", "is_generated": true, "generator": "test-lab-match-check@SynomosAI",
                "content_type": "decision_support_output", "disclaimer": "决策支持非权威结论，须人工复核；以官方最新文件为准"}
}

（obligations / notes 数组字段值逐字未改，此处折叠。）

三档 rc 实测：--device_type implant --material metal --contact implant --sterile yes --steril_method eo --dest cn → rc=0；--device_type active --sterile yes → rc=1（缺材料/灭菌方式从严提示）；--device_type ivd --contact garbage / --dest jp → rc=2（枚举非法）。

五、能力边界（请务必阅读）

• 只做规则判定，不做法律意见、不出具证明；结论须人工复核，最终以监管机构/公告机构认定为准。
• 输入不足时从严提示：缺 --material、声明无菌但缺灭菌方式等均在 warnings 中明示（rc=1），不静默按宽松清单输出。
• 不覆盖特殊情形（创新器械、药械组合、边界产品、纳米材料等），此类须走官方界定程序。
• 规则版本会变；条款号已给出，请以官方最新文本核对。
• 输出为起始清单，不替代产品技术要求、适用标准清单与专业评价者判断。

六、理论依据

有门禁先立标准——检测是把「合规」变成可复核数据的那道闸。

域站位件：TH-MED-010 · LGD 理论总账 REGISTRY · 医疗器械全链路治理（有籍 · 有证 · 有门禁）

七、家族合集（按注册全流程）

诺衡@MED 域·合规核查 · TH-MED-010 · © 2026 SynomosAI · MIT License 本内容由 AI 辅助生成（非自然人），署名机构承担出品责任。