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医械法规术语库与译稿质检

医械法规中英术语库与译稿质检：164 条标准术语速查（ISO 13485 / ISO 14971 / ISO 10993 / IEC 62304 / MDR 2017/745）、36 条高频误译规则体检、中英双语对照质检（警示语强度弱化 / shall 情态丢失 / 标准号被翻译）。适用于 IFU、标签、CER、技术文件的翻译与审校。

personAuthor: StevenZhao26hubOpenAPI
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MedXpert Termbase (医械法规术语库与译稿质检)

When to Use

  • You are drafting or reviewing a bilingual medical-device document (IFU, label, CER, technical file, test report, audit report) and need the standard Chinese/English rendering of a regulatory term.
  • You want to catch known mistranslations before submission — the traps that repeatedly show up in Chinese medical-device translation (过程验证 vs 过程确认, 临床实验 vs 临床试验, CE 认证 vs CE 标志, …).
  • You have an EN source and a ZH translation and need a cross-language QA pass: did every WARNING survive, did shall become a suggestion, did a standard number get translated away.
  • You need a standard number written correctly (ISO 13485, GB 9706.1, 510(k)) rather than in a half-translated or malformed form.

Bundled Assets

| Path | What it is | |---|---| | references/termbase.tsv | 164 entries: en, zh, note, kind (term / keep-as-is / warning-level / modal-verb) | | references/mistranslations.tsv | 36 high-frequency mistranslation rules: bad → good, reason, severity | | scripts/term_check.py | The tool (stdlib only, no dependencies) |

Usage

# 1) term lookup (substring, EN or ZH)
python scripts/term_check.py lookup biocompatibility
python scripts/term_check.py lookup 风险

# 2) termbase inventory
python scripts/term_check.py stats

# 3) single-document lint (Chinese or English draft)
python scripts/term_check.py check draft_zh.md

# 4) bilingual QA on an EN/ZH pair
python scripts/term_check.py pair ifu_en.md ifu_zh.md

Exit code 0 = clean, 1 = findings, 2 = usage error.

What the Checks Actually Do

check <file>

  1. Forbidden renderings — every rule in mistranslations.tsv is matched literally against the draft, reporting 「bad」→ 应为「good」 with the reason. Severity: error / info.
  2. Standard-number form — for each canonical code in the keep-as-is set (ISO 13485, ISO 14971, IEC 62304, GB/T 16886, …) it flags missing spaces, lowercased agency prefixes and stray colons (ISO13485, iso 13485, ISO：13485).

pair <en_file> <zh_file>

  1. Warning-level ledger — counts DANGER / WARNING / CAUTION / NOTE in the EN source against 危险 / 警告 / 注意·小心 / 提示·说明 in the ZH translation. Flags: a level present in EN but absent in ZH (dropped warning), a level whose ZH count falls short (partial loss), a level the ZH side invented, and — the recurring one — CAUTION silently downgraded to 提示/说明.
  2. Modality ledger — shall vs 应/须, should vs 宜, may vs 可以. Flags shall with no ZH obligation word (a requirement weakened into advice).
  3. Standard-number parity — any standard code cited in the EN but absent from the ZH (standards are never translated or dropped).

Chinese modal counting strips non-modal compounds (反应, 相应, 应用, 适宜, …) so 应 and 宜 counts are not inflated by ordinary vocabulary.

Translation Rules This Skill Enforces

| Rule | Why | |---|---| | Standard numbers, regulation names and agency names are never translated | ISO 13485 stays ISO 13485; writing 国际标准化组织13485 breaks traceability | | One term, one rendering — do not vary within a document | Regulators read consistency as a proxy for control | | Warning strength may be equal or stronger, never weaker | WARNING may not become 注意; CAUTION may not become 提示 | | validation → 确认, verification → 验证 | process validation = 过程确认; mixing them is the most common QA finding | | must → 应 (shall) in formal documents | 必须 is conversational emphasis, not specification language | | Recall wording follows the target market | US Recall / EU FSCA / CN 召回 — do not mix |

Known Limits (be explicit with users)

  • The termbase is a curated working list (~164 entries), not an official glossary. There is no ISO-endorsed Chinese translation of ISO 13485 vocabulary; always defer to the applicable national standard's own wording (e.g. GB/T 42061 for ISO 13485, YY/T 1437 for ISO 14971 terminology) when a regulator will read it.
  • The pair mode is a statistical parity check, not an alignment. It compares counts, not sentence-by-sentence correspondence — a legitimate restructuring can produce a flag. Treat findings as "go look here", not as verdicts.
  • check only finds listed traps. A clean run means "none of the 36 known traps and no malformed standard number", not "correct translation".
  • The skill does not translate. It reviews.

Output Discipline

  • Report the finding with its line number, the offending text and the suggested replacement — never a bare "translation has issues".
  • Distinguish error (contradicts a published convention) from info (house style / writing preference).
  • If a term is not in the termbase, say so and suggest confirming against the applicable standard's own vocabulary instead of inventing an entry.