/**
 * IEC 62304 Medical Device Software Compliance Pack
 *
 * IEC 62304:2006+A1:2015 -- "Medical device software -- Software life cycle
 * processes." International Electrotechnical Commission (IEC) standard that
 * specifies life cycle requirements for the development and maintenance of
 * medical device software.
 *
 * Standards referenced (citations only; no verbatim text from the standard):
 *   - IEC 62304:2006+A1:2015 -- core software life cycle processes
 *   - IEC 62304 Annex B -- software safety classification rationale guidance
 *   - ISO 14971:2019 -- risk management for medical devices (required input
 *     to IEC 62304 software safety classification)
 *   - IEC 82304-1:2016 -- health software; complements IEC 62304 for
 *     standalone health software
 *   - FDA Guidance "Content of Premarket Submissions for Device Software
 *     Functions" (2023) -- cites IEC 62304 as the referenced standard
 *   - EU MDR 2017/745 + MDCG 2022-2 -- reference IEC 62304 for EU CE marking
 *   - IMDRF SaMD Framework -- references IEC 62304 processes for SaMD QMS
 *
 * Software Safety Classes (IEC 62304 §4.3):
 *   - Class A: No injury or damage to health is possible from failure
 *   - Class B: Non-serious injury is possible from failure
 *   - Class C: Death or serious injury is possible from failure
 *
 * Process requirements scale with class:
 *   - Class A: Basic documentation, maintenance process, anomaly resolution
 *   - Class B: Class A + detailed unit-level architecture, integration testing
 *   - Class C: Class B + detailed design, unit verification, full traceability
 *
 * SOUP (Software of Unknown Provenance -- IEC 62304 §3.1.17):
 *   Any software item that is already developed and generally available,
 *   and that has not been developed for the purpose of being incorporated
 *   into the medical device. Third-party libraries, OS components, LLM
 *   inference libraries, and AI framework packages all qualify as SOUP.
 *   Class C SOUP introduction without documented evaluation is BLOCKED.
 *
 * Retention:
 *   IEC 62304 §5.1.1 requires software development plan records to be
 *   retained "for the expected lifetime of the medical device." Combined
 *   with FDA 21 CFR 820 (QMSR), EU MDR PMS, and MHRA guidance, the
 *   effective minimum retention is 10 years (device lifetime + post-market
 *   surveillance period).
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
/**
 * IEC 62304 category classifiers.
 *
 * Covers SOUP identification, software safety class declarations,
 * risk management file data, anomaly reports, configuration items,
 * and software safety classification artefacts.
 */
export declare const IEC_62304_CATEGORY_CLASSIFIERS: CategoryClassifiers;
/**
 * IEC 62304 Medical Device Software Compliance Pack.
 *
 * Pack ID: 'iec-62304'
 * Jurisdiction: International (IEC standard; adopted globally by
 *   FDA, EU MDR/IVDR, MHRA, TGA, Health Canada, and others as the
 *   referenced software life cycle standard).
 *
 * Guard-layer wiring:
 *   - G1-G4 (audit, logging, classification, session): always active
 *   - G5-G6 (supply-chain, approval-queue): Class B and C only
 *   - G7-G9 (attestation, anomaly-detection, transparency): Class C only
 *   - Approval Queue: always active (mandatory for anomaly triage)
 *
 * Human-in-loop tier:
 *   - T1: Class A (basic human review for anomaly closure + SOUP approval)
 *   - T2: Class B + C (specialist clinical safety review required)
 */
export declare const IEC_62304_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
    subjectKeyedCategories: string[];
};
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